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

Food defense is not food safety – defined, food defense is “the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents introduced for the purpose of causing harm.” Being a food safety geek, I recently returned to Minneapolis to attend the conference of the Food Protection and Defense Institute. FPDI is a Department of Homeland Security Center of Excellence, serving the food industry in the fight against intentional adulteration since 2004. As a food safety geek, I am intrigued about food defense and want to learn more. Maybe you are intrigued too. Here I have compiled five key resources for you to start your own journey down the path of food defense.

    1. Food Protection and Defense Institute

      I love the folks at FPDI. For people who think about crime for a living, they are really nice, normal people. At the conference they showcased local to international speakers, but their website is the star of the show. Here are some of the features of the FPDI website:

        • Food Defense Online Training
        • Food Adulteration Incidents Registry (FAIR)
        • World Factbook of Food
        • Food Defense Readiness Assessment
        • Focused Integration of Data for Early Signals (FIDES)
        • Intentional Adulteration Assessment Tool

      Finally, collaboration through two platforms:

        • CoreSHIELD
        • FoodSHIELD

      The platforms allow secure sharing of resources among the food defense community. FPDI works globally to monitor food defense.

    2. FDA at a Glance: FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

      While most government documents are good for sleepless nights, I have learned to pay attention to fact sheets and question-and-answer publications from the FDA. These documents condense the information down to the most important facts. FDA published At a Glance documents for each of the seven foundational rules of FSMA. The Intentional Adulteration rule, AKA food defense rule, focuses on who is covered, what the key parts are for a food defense plan, compliance dates, and exemptions. As always, industry is welcome to submit questions to FDA about the rule through its Technical Assistance Network.

    3. FDA Voice, by Scott Gottlieb, M.D., March 28, 2018

      In FDA Commissioner Gottlieb’s blog post, We’re Committed to Guarding Against the Intentional Adulteration of Food and Implementing the New Rule Efficiently, we get the latest information straight from the top. I have seen and heard this article cited many times since its release. There is reference to FDA guidance in the article. At the FPDI conference, we were told the FDA guidance for the Intentional Adulteration rule is close to publication. Once available, that guidance will be another resource for industry.

    4. Food Safety Preventive Controls Alliance

      For food safety geeks, FSPCA is the go-to source for training and other resources. FSPCA is the hub for writing the curriculum for the Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification rules. The food defense rule requires training also. The first food defense training from FSPCA is available now, and it is FREE! From the FSPCA website, According the IA rule, individuals assigned to work at actionable process steps and their supervisors, are required to receive training in food defense awareness (21 CFR 121.4(b)(2)). This training is called Food Defense Awareness for the IA Rule. Your employees will need about 20 minutes to complete the online training and a printer to print the training certificate.

    5. Matthew Botos, CEO, ConnectFood

      After September 11, 2001 ConnectFood‘s own Matthew Botos developed a food defense program for the food industry. He was ahead of the curve, as usual, taking action before the Food Safety Modernization Act of 2011 or even the signing in 2004 of Homeland Security Presidential Directive-9-Defense of United States Agriculture and Food.

Either food defense or food safety, we are all in this together. 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

The FDA inspector shows up at your door and requests to see your approved suppliers in 2017. Can you retrieve those records easily? The Preventive Controls for Human Food rule requires you to retrieve records within 24 hours upon request. Think of the nuts, seasoning, and cheese used as ingredients requiring supplier approval. With electronic record management in the “cloud,” you can display the record on the spot.

Written procedures are required. Those four words can put the best owner or quality manager over the edge. Writing documents is time-consuming. I was recently writing a HACCP plan with a restaurant owner and trying to capture all the required written procedures. We know most training and learning at a restaurant is achieved with verbal instruction and shadowing. Restaurants operate by “do-as-I-do” methods and “this is how we do it.” It was difficult to write procedures for steps that have no written documents. Maybe you know the feeling. However, written procedures and other documents are required for FDA compliance with the Preventive Controls for Human Food rule.

Because recordkeeping and record management are so important, I have written many times about specific topics which require record management. For example, supplier verification starts with supplier approval and includes an on-site audit, Certificates of Analysis, sampling and testing and possibly more. All those records must be managed. In a previous blog post on records management, I discussed what counts as a record. The perspective of that writing was focused on worksheets, bench sheets and electronic records. In other words, that was data input. Here my focus is on written procedures.

If the procedure controls food safety, the procedure must be written.

The food industry is rising to a higher level of food safety through written procedures. Written procedures are helpful for several reasons.

    1) Once the procedures are written, the requirement will be met. You must write out the procedures to be in FDA compliance.

    2) When forced to write the procedure, the action of writing makes you question why procedures are done the way they are and if the procedure is correct. For example, let’s say you are writing the procedure for mixing a sanitizer concentrate with water. What is the concentration of the concentrate? How much concentrate is mixed with how much water? What tools are used, and where are the tools located? Finally, why? How do you know this solution is correct? Once you know the solution is correct, will the solution adequately act as a sanitizer? This type of questioning will be applied with the writing of each procedure.

    3) You will review each method at some frequency to confirm the procedure is still being done as written. With review, any drift from the intended procedure is streamlined to get back on track. Using the preparation of sanitizer solution again, what if the measuring cup for the concentrate cracks and is replaced by a different cup? The new cup looks close to the original cup, but by following up on the procedure, it is determined that the new cup is bigger and too much concentrate is being added. That is money down the drain! You may find one employee who does the procedure differently from another employee. The review is a step in continuous improvement.

    4) The written procedure will be used for training and re-training employees. The written procedure provides a recipe for training employees. Everyone gets trained by the written procedure, in addition to on-the-job training. If there is a food safety issue with a procedure, the written procedure can be reviewed for compliance by employees and changed if needed. Supervisors can use the written procedure as a guide for observations during an internal audit or employee review.

Under Expert Services (go to the bottom of the webpage) from ConnectFood, you can partner with a food safety expert for the writing and review of your company’s procedures. The ConnectFood website also 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

Your company is generating a record right now. Somewhere in the facility there is monitoring, a new employee is being trained, or ingredients are being shipped to you. I have written in previous posts here on ConnectFood.com about required and recommended records. Below is an outline of topics which generate records in need of management.

What records must my company have?

    Good Manufacturing Practices (GMPS). Every food facility is required to follow GMPs.* You will feel confident in an inspection or audit if you have good documentation for GMPs.
    Standard Operating Procedures (SOPs)

      Sanitation Standard Operating Procedures (SSOPs) are required when a sanitation preventive control is identified in the hazard analysis and for some allergen preventive controls.*

    Training records*
    Hazard Analysis*
    Validation study for each process preventive control or critical control point*
    • Shelf-life study, recommended
    • Supply chain program

      Supply chain preventive controls are required for ingredients for which the supplier controls the hazard.*

    Receiving records for ingredients with a supply chain preventive control*
    • Monitoring and Verification*
    • Calibration of monitoring devices*
    • Equipment maintenance, recommended
    • Corrective action*
    Recall plan*

*Required by the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule.

“How do I store all these records?”

This is a question I always get in a training workshop. It usually starts with, “I have a HACCP plan” or “I have records for auditing” and proceeds to the concern of getting rid of everything that has been done up to now and starting over. The answer is an emphatic “No!” to starting over. Your company is not going to rid itself of the old systems and start with the new kid on the block. Everything you have done for record keeping is still valuable and fits into the new food safety or HACCP plan. The next question is harder. “How do I organize my food safety plan and my required records for audits?” Unfortunately, I can’t answer that question, because it is completely up to you.

Matthew Botos, CEO of ConnectFood, did have a response to the above question:

“Records are of the utmost importance in the food safety risk management system. As I have said probably thousands of times (as have my peers): “If you haven’t documented it, you have not done it.” Records have traditionally been paper records, but over the decades with advancements in technology we are now ready to “trust” electronic records. As always, they are only as good as the information we put into them. What I can tell you is that there are companies like ConnectFood which will facilitate the storage and retrieval of records. In the electronic world that we live in, electronic storage of records is no longer just the future, it is the present.”

When the FDA inspector requests review of an electronic record, there is no requirement to supply a paper copy or printout. Records can be stored in the “cloud” if they can be retrieved. Imagine being on the floor in operations with an inspector and you are asked for the pH meter calibration record from a year ago. You can pull up the record on your phone or tablet and move on to the next question.

For your ease of mind, it is important that you understand how electronic records are stored and retrieved at your company so that you can efficiently display the record for review. What I tell my workshop participants and clients is to find the person at your company who loves office supplies. This is the tell that they love to sort, store, and organize things. Do they have every color of highlighter? I do. Do they have a label maker? I do. While my desk is often messy, my office supplies are organized and labeled. If you need a pad of paper, this person knows exactly where to get one for you. This is the person you want to task with organizing records electronically, too. As quality manager or Preventive Controls Qualified Individual (PCQI) you have too much on your plate, and I want you to delegate when possible.

Once a system for records management is created, all food safety team members should be required to follow the system. There should be no stray records being held outside of the system and unavailable to the entire team. Never rely on one single person having access to part of the records. Store electronic records in a common location for two or more years.

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

Most food manufacturers do not have a supply chain preventive control and will not have supplier verification in their written food safety plan. A separate blog post of mine, Supply Chain Preventive Controls, discusses identification of a supply chain preventive control.

    1. Supply chain preventive controls are required for ingredients where YOUR suppliers control the hazards.
    2. A supply chain preventive control is required for imported packaging when a hazard is identified.

The safety of imported ingredients and imported packaging is enforced under the Foreign Supplier Verification Program (FSVP) rule. See the Preventive Controls for Human Food rule for supplier verification.

I get a Certificate of Analysis (COA) with my ingredient. I’m good, right?

Good, but you are not done. The way I approach supplier verification is as an attorney collecting evidence to build a case that a jury will decide. You are the attorney, and FDA is the jury. The burden of proof is on you to demonstrate the ingredient is safe. Yes, it is all about verification. Your FDA inspector will review your supplier verification.

Before we go on to the requirements and just checking in, have you identified a hazard requiring a supply chain preventive control? If the answer is yes, read on!

Requirements for Supplier Verification

    1. Supplier approval
    2. COA or similar document with receipt of every shipment
    3. Sampling and testing for hazard
    4. On-site supplier audit

      a. Use of a qualified auditor
      b. Proof of corrective action implementation

This is an extensive list and a lot of work to prove the hazard was controlled by the supplier. Let’s look at an example with peanut butter as an ingredient in a candy bar. The peanut butter is not further processed to control hazards, and supplier verification for the peanut butter is required for the control of hazards like pathogens Salmonella and Listeria monocytogenes, aflatoxin, and physical hazards. The United States had two major outbreaks from Salmonella in peanut butter, and other nut butters are under heavy scrutiny by the FDA.

Supplier approval. The approval process is not mandated, so you have flexibility on how you determine the supplier is approved. Include the written Standard Operating Procedure (SOP) for supplier approval in your food safety plan. You are required to document the supplier is approved. You are encouraged to complete this process before using the ingredient from this supplier. If not approved before you’re your Preventive Controls Qualified Individual (PCQI) must document in the food safety plan the timeline and justification for later approval.

In both peanut butter outbreaks, part of the blame lies with the customers not doing enough for supplier approval and verification. If you are purchasing an ingredient in which the pathogens are killed, the supplier is required to use a validated process preventive control. Ask for the results of the validation study and documents proving the process is validated, monitored and verified. Some suppliers are not willing to share this information. If a supplier is not willing to share food safety data, you may want to start searching for another supplier. Will you share with your customers?

Written procedures are required for Receiving for ingredients with a supply chain preventive control.

Specifications and COAs. Once the supplier is approved, you will set specifications for the absence of the hazard; that would be the absence of Salmonella and Listeria in the ingredient of peanut butter in our example. When the peanut butter is received, the Receiving personnel should inspect the vehicle for sanitary conditions and the containers to ensure they are intact. The bill of lading is checked against the goods received upon arrival. Every shipment of peanut butter must include a document stating the hazard is absent. With every shipment received, you get a COA, a Certificate of Conformance (COC), or letter of guarantee regardless of repeating a lot code. The ingredient container or pallets should be clearly labeled at Receiving, then moved and stored in a manner to prevent cross-contamination and cross-contact.

You cannot continue to just file away COAs for ingredients where a hazard is controlled by a supplier.

Sampling and testing. FDA requires verification of COAs at some frequency determined by you. Are you still with me that this is for ingredients where the hazard is controlled by the supplier? Develop a sampling plan for each ingredient to include:

    • who is responsible for sampling and how they are qualified,
    • the location where samples are taken,
    • the methods for sampling and shipping,
    • the number and size of samples,
    • the coding of samples,
    • the exact location of the laboratory, and
    • the method of the test.

Often the customer drives the sampling plan and orders too many samples and too many tests. Please do not order tests where you do not use the data. Don’t get me started on this! As the customer, you must be confident in samples being taken and shipped properly. You must trust the results of the laboratory. Work with experts to develop your sampling plan.

On-site audit. At first glance, the requirement for an on-site audit of the supplier seems daunting. However, you do not personally have to do the audit. You may use the audit of another body for your documentation. That means you can use the audit report from a state inspector, federal inspector, broker, consultant, or auditing firm. There is a requirement for a qualified auditor, not a certified auditor. You are required to prove to an inspector how an auditor was qualified to inspect your supplier. After the initial inspection, an annual audit is required, unless there is justification for a less frequent audit that is based on evidence. Work with a qualified auditor to put together your auditing plan. After you have agreed upon the scope of the audit and how the audit will address the hazard, you must obtain all corrective action and implementation documents to address problems.

Your job is to collect evidence to prove your case for safety. Confidence will climb for your case before an FDA inspector, when you have an approved supplier, documentation of receipt of the ingredient, verification of COAs for the hazard, and results of on-site audits.

If you want to read the requirements for supplier verification, find Subpart G in the Preventive Controls for Human Food rule. However, I recommend starting with the FDA At-a-glance document which provides a neat summary of the rule. Still not sure if you are meeting the requirements for supplier verification? 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

May 2, 2018 Update
Both the FDA and CDC published updates on the pathogenic E. coli outbreak today. Sadly, one death was reported. This blog post was published earlier in the day and has been updated below the original post.

Romaine Recall: What You Should Know

There is an outbreak of pathogenic E. coli in the US. The Centers for Disease Control and Prevention (CDC) through PulseNet, a national database, recognized the outbreak in March 2018 with the initial CDC announcement on April 10, 2018. With the initial announcement, there were 17 cases across seven states with the largest number identified by the New Jersey Department of Health.

What do we know about the outbreak?

    • The pathogen is Shiga toxin-producing Escherichia coli O157:H7.
    • The likely source is Romaine lettuce.
    • The Romaine lettuce is from the Yuma, AZ growing region.
    • Illnesses started March 13th, 2018.
    • 22 states.
    • 98 cases ranging in age 1-88.
    • 46 hospitalizations, including.
    • 10 patients with hemolytic uremic syndrome, a form of kidney failure.
    • 0 deaths reported.
    • 65% of cases are females.
    • Dozens of farms in the Yuma, AZ region are being investigated.

How do we know what we know?

    • When a clinical isolate from a patient is identified as E. coli O157:H7, the result is reported to the state department of health. The state reports the result to the CDC. The isolate is tested by pulsed field gel electrophoresis (PFGE) and the data are entered in the national PulseNet database. The CDC monitors the database and sees the matches across multiple states. There are differences in strains of E. coli O157:H7, and PFGE is used to show matches of the same strain. The outbreaks isolates are also tested by whole genome sequencing (WGS), a method to fingerprint the strains.
    • Health departments conduct food surveys of patients to learn foods eaten. For this outbreak, 64 of 67 patients interviewed reported eating Romaine the week before the illness started.
    • The Yuma, AZ growing region provides Romaine to the US during the winter growing months.
    • The CDC epi curve shows the first case had an illness start date of March 13th.
    • The CDC Case Count Map shows the number of cases per state.
    E. coli O157:H7 was traced back and found from one farm in Yuma, AZ, after cases developed at a correctional facility in Alaska where whole-head Romaine was shipped. This one farm has not been called the sole source of the outbreak, and the investigation continues in the Yuma, AZ growing region

What do we expect?

    • Illnesses started after April 7th may not be reported yet, so the number of cases will increase. The timeline for the illness and outbreak is:

      1. Onset time is 1-8 days.
      2. Duration of the illness is 5-10 days.
      3. Medical diagnosis can be 2-3 weeks.
      4. PFGE and WGS conducted.

    • Watch for another CDC update on the number of cases and hospitalizations.
    • The investigators will locate the source of E. coli O157:H7. The isolates will be tested by PFGE and WGS. The results from the source will be compared to the patient isolates to detect matches.
    • The number of cases will taper off and the outbreak will be over, due to the end of the Romaine growing season in Yuma, AZ.

What can you as a consumer do?

    • Do not eat Romaine from Yuma, AZ or if the growing location is unknown.
    • Do not eat salad blends containing Romaine, if the growing location is unknown.
    • Do not eat salads, if you do not know if the salad contains Romaine.
    • As we start the summer season, follow the rules of clean, chill, cook and combat cross-contamination.
    • Finally, my favorite rule is, “When in doubt, throw it out.”

Updated information from the CDC and FDA, May 2, 2018

    • The last reported illness started on April 21, 2018.
    • The number of states has increased to 25.
    • The number of cases has increased to 121.
    • The number of hospitalizations has increased to 52.
    • The number of patients with hemolytic uremic syndrome is 14, up from 10.
    • California reported one death.
    • CDC investigations are ongoing.
    • As expected, the growing season is over for the Yuma growing region as reported by the Arizona Leafy Greens Marketing Agreement on April 27, however, Romaine has a 21-day shelf life which puts Romaine with consumers until mid-May or longer.

Because of the timeline for illness and outbreak detailed above, additional cases are expected. I want to note that growers who participate in the Arizona Leafy Greens Marketing Agreement implement strict procedures for food safety. The grower who sourced to Alaska is an active participant in the Agreement and highly regarded for compliance in food safety. Participants must have a food safety plan, employee training in food safety, pass an audit and pass inspections. I hope that the source of the contamination is discovered, and the growers will come back even better than they already were. Food safety is not competitive, and we are all in this together.

Correction: The original blog stated that E. coli O157:H7 was found from one farm in Yuma, AZ. That is not correct as the FDA continues to investigate the source of the pathogen along the supply chain. FDA traced the source of the Romaine shipped to Alaska back to one farm in Yuma, AZ.

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

I heard that inspections are looking more like audits than the historical walk-through and observation of employees working. Why is that? Documentation is required by law and tells the story of food safety. The success of your company inspection lies in your records. Today I am writing some good, general concepts and requirements on records management under the Food Safety Modernization Act’s Preventive Controls for Human Food rule.

What is the purpose of records management?
This is the way I look at it: your company (and most of the food manufacturers in the United States) are making and selling a safe product. The bad ones who intentionally sell harmful products go to jail – these are rare. Then there are the companies who think they are doing the right thing, and they simply do not know their product is potentially harmful. For example, there is the national recall of Romaine lettuce contaminated with E. coli O157:H7. Something is wrong with the Romaine system, and hopefully the problem will be found and fixed.

For everyone else, you are making a safe product. You are the expert for your ingredients, personnel, equipment, and customer base. However, when the inspector shows up at your door, what records do you have as proof that you are making a safe product? You have a written food safety plan, written procedures, and supporting documentation. Through good record management, you can show the inspector records from receiving to shipping. Have you ever sat on a jury panel? Like the lawyer presenting evidence for the case, your company compiles evidence of food safety and, in turn, presents that evidence to an inspector.

What counts as a record?
Any and every written document can build your case. Records can be handwritten, hard copy documents, or you can create them with an electronic record. A true copy of the record is made with a photocopy or scan of the original in case of an accident that destroys the bench sheet. In addition, handwritten records must be recorded in permanent ink, preferably blue or black, and at the time of the observation be neat enough to read and provide enough detail to prove safety.

What information is required on the record?
Information must be complete to document the safety of the product. As you think through the possibility of a product recall, what information would you need and what information does the FDA and state recall coordinator need? Every document created at your company must include the name and location of the company. Location is critical if there is more than one facility, such that the document shows where the record was made and reflects the safety of the product made at that location. On the record sheet, include the name of the record, date of record, initials of employee recording data, and signature or initials of the company’s Preventive Controls Qualified Individual (PCQI) for record review, along with the date of the record review. Note the time the observation was recorded too, if time is important. Record the name of the product and lot code for the batch. Again, think through what information you would need in the event of a recall.

Complete information discussed above is required in electronic records just like in a bench sheet. The same is true for a temperature chart or any record automatically generated. Don’t forget record review as a verification step by a PCQI.

What do I do with all these records?
It is completely up to you to choose paper or electronic records – or a combination of both! By law, you must store records related to food safety for two years. However, the food safety plan must be reviewed within three years, and if records are related to the food safety plan, those records may need to be stored longer. The easy part is electronic records – no matter where the data are stored electronically, if the record can be viewed on site, the record is considered stored on site. The hard part is paper records – if your company runs out of room to store boxes of records, they can be stored off site, provided that upon request of an inspector, the records can be retrieved within 24 hours. There are companies that provide off-site storage and retrieval as a service.

Going beyond the discussion of generalities, there are required records for hazard analysis; preventive controls and their monitoring, verification, and corrective action; validation; recall plan; training records and records in support of Good Manufacturing Practices. The folks at ConnectFood will design Record Management with you and 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