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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

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

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

This week was a historic week for the federal Food and Drug Administration (FDA). Three times since the signing of the Food Safety Modernization Act (FSMA) in 2011, FDA has used its new authority, i.e. new tools to prevent illness or injury from food. In 2012, FDA suspended the facility registration of Sunland, Inc. of Portales, New Mexico, a manufacturer of peanut butter. In 2013, FDA sent a Notification of Opportunity to Initiate a Voluntary Recall to Kasel Associates Industries, Inc., a manufacturer of pet treats. This week, FDA ordered a mandatory recall of kratom products from Triangle Pharmanaturals, LLC of Las Vegas, Nevada.

The FDA used its authority under FSMA to order a recall. This is a big deal. In all the history of food safety and the FDA, this is the first time the FDA has announced a mandatory recall. There have been thousands of recalls in FDA’s history, and before this week, every single recall has been voluntary and announced by the company.

What were FDA’s options before FSMA? Traditionally, FDA has followed up inspections with Form 483. Observations are detailed on Form 483, and the company must respond with corrective action to each observation. FDA has written soft letters, had phone conversations and sent email messages to communicate. Beyond communication and for more action, the FDA sends Warning Letters and can go to federal court to seek either an injunction to halt sale of product or an order for seizure of product. Product seizure can be taking product off store shelves or stopping finished product from entering commerce. Those are a lot of options! In the three cases stated above, FDA used many tactics to communicate and work with the companies, before getting to the last straw.

Case 1. Sunland peanut butter sold finished product containing Salmonella.
A little research on Sunland shows a long history of peanut butter recalls and FDA communication from 2009 to 2012. Just a year and a half after President Obama signed FSMA and four years before the food industry came under compliance and enforcement, the FDA exercised its new authority. For my readers who favor less government and less rules, look at what FDA did before pulling Sunland’s registration:

    1. 2007: Form 483 following inspection 10/25/2007
    2. 2009: Form 483 following inspection 3/10/2009
    3. 2010: Form 483 following inspection 9/23/2010
    4. 2011: Form 483 following inspection 3/25/2011
    5. 2012: Form 483 following inspection 10/29/2012

For the 2012 inspection, FDA was on-site for one month and listed the details of ten observations. Given authority under FSMA, FDA was able to stop production of Salmonella-laden peanut butter. The Centers for Disease Control and Prevention (CDC) reported the Salmonella outbreak from Sunland peanut butter covered 20 states and was responsible for 42 cases. Children under 10 were 61% of the cases, and 28% of cases were hospitalized. We know that diagnosed and reported illnesses represent a small portion of all persons with illness from an outbreak. Dozens of companies using peanut butter in their products went through subsequent recalls because of the peanut butter recall. I know, because it was my job to follow recalls and post them to ConnectFood’s Twitter.

Case 2. Kasel dog treats recalled after Salmonella found.
FDA has authority for enforcement and compliance over animal food. In February of 2013 Kasel was manufacturing dog treats and was re-inspected. In a 2012 inspection, Salmonella was found in the dog treats, in the processing environment, and on food contact surfaces. FDA inspectors cited problems with Kasel’s Good Manufacturing Practices including building repair, pest control and cleaning and sanitizing procedures. The dog treats had either a one-year or two-year expiration date. Kasel was given two days to initiate a voluntary recall after receiving FDA’s Notification of Opportunity to Initiate a Voluntary Recall, and Kasel complied by announcing a voluntary recall on February 19, 2013. Here’s my favorite sentence from the Notification: If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats. Fast-forward to 2018. FDA is rigorously inspecting animal food manufacturers, and we have seen a wave of pet food recalls [author’s note: choose Animal Health for from the drop down menu of recall categories], primarily of raw pet food.

Case 3. Triangle Pharmanaturals’ kratom products contain Salmonella.
Remember all those options available to the FDA? It seems the FDA used them and got no response from the company in return. FDA sent Triangle Pharmanauturals a Notification of Opportunity to Initiate a Voluntary Recall with no response from the company. All companies in the past which have received this letter from the FDA have followed up with a voluntary recall, because this is the first company which has not! This is the evidence I have gathered against Triangle Pharmanaturals. There is currently (April 2018) a multi-state outbreak of Salmonella. During interviews in March of people ill from Salmonella, when specifically asked, 40 of 55 reported consuming kratom before getting sick. Salmonella has been isolated twice from Triangle Pharmanaturals’ products by the state of Oregon and four times by FDA. Triangle Pharmanaturals’ competitors have recalled their kratom products. As I am writing this, I received updated recall information to include 38 states and 132 confirmed cases.

These three companies have in common that their products contained Salmonella. To me as a microbiologist, that is interesting. More importantly, their company names are forever tied to the history of FDA in the fight of foodborne illness. Personally, I am thankful for the work of the FDA and CDC.

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

FDA published the draft guidance Determining the Number of Employees for Purposes of the “Small Business” Definition of Parts 117 and 507: Guidance for Industry on March 19, 2018. The comment period is through May 20, 2018. The purpose of the guidance is to raise awareness of exemptions for Part 117, the human food rule, and Part 507, the animal food rule. There is also a later compliance date for small businesses under the animal food rule of September 17, 2018, than originally set. I am addressing human food within this blog.

Why did FDA publish this draft guidance?
I’m having a difficult time understanding the publication of this Food Safety Modernization Act (FSMA) draft guidance at this time. It is helpful in defining subsidiary, affiliate, facility and full-time equivalent (FTE) employee. There are clear examples to showcase types of facilities and calculations of FTEs. The purpose of calculating FTEs is to determine if a facility is defined as a small business of less than 500 FTE employees. This is a concern when multiple facilities are related and if there are part-time or seasonal employees. This is a question I have tried my best to address in PCQI workshops for my participants. It’s nice to have the draft guidance. The reason I am having a difficult time is that it is a moot point for industry now. All small businesses came under enforcement in September 2017 for human food. Small businesses must meet the same requirements their larger competitors met in September 2016.

    I believe the reason for the publication of the draft guidance
    is not as much for industry as it is for the FDA.

Will my facility be inspected?*
FDA prioritizes their inspections, so FDA must know if a facility is a small business or larger. In fiscal year 2016-2017 when businesses with more than 500 employees came under enforcement, FDA’s goal was to complete 300 FSMA inspections. Facilities with more than 500 employees were under inspection first, because of the potential public health impact to a larger number of consumers. A total of 165 domestic and foreign FSMA inspections were completed. All other inspections-the majority-were Good Manufacturing Practices (GMP) inspections. That trend will continue with most inspections being GMP inspections. The FDA continues to train its inspectors on FSMA, and FDA inspectors are primarily in a FSMA educator mode with industry. In fiscal year 2017-2018 the goal is higher at 500 FSMA inspections; the pace is faster.

In addition to the number of FTEs, there are other factors used by FDA to prioritize inspections.

    • Domestic and foreign facilities goals are 400 and 100 inspections, respectively.
    • Facilities with a current or previous Class I recall or warning letter
    • Facilities in the same market as a facility with a Class I recall
    • Facilities making a high-risk ingredient or product

      1. Ready-to-eat foods
      2. Foods identified in FDA’s Listeria risk assessment
      3. Foods otherwise with a history of risk

While it is not possible to know if your facility will be inspected until the FDA inspectors are at your door, you can determine the likelihood by using the same tools FDA has to prioritize inspections.

*The author participated in a Food Safety Preventive Controls Alliance quarterly webinar for Lead Instructors on February 8, 2018, in which FDA inspection data was shared.

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

All of us have our personal culture in which we live. How we spend our time at home and on the weekend creates our culture. The time we spend with our neighbors, friends, family and church defines us. Think of the clothes we wear, the food we eat and our traditions. Now think of the culture at your work. Think of the clothes we wear, the rituals in our procedures, and the food we make for customers. What is the status of your food safety culture?

When the FDA inspector visits your facility, the inspector will be looking for evidence of a good food safety culture. If you work in food safety or quality management, you work hard. You wear many hats. When the FDA inspector comes, your records will be inspected, and your employees will be observed. You prepare for that. You have good, organized records. You have good training programs for your employees. Most companies are confident in addressing records and training and making the evidence appear for the inspector. While the inspector is reviewing records and observing employees, the inspector is looking for evidence of a food safety culture. This is touchy-feely and sometimes hard to document. The culture is who you are and how you work together.

What does food safety culture look like? Start with your employees. Are the uniforms clean? Is their footwear of good quality and cleanable? How is their personal hygiene? Do all employees practice good handwashing? These observations plus good recordkeeping lay the foundation of a favorable food safety culture. These parts of a food safety culture are obvious to most and will be discussed more in this blog. In a second blog, I discuss 5 Signs You Don’t Have a Food Safety Culture.

Training records are complete for each employee.
Under the Food Safety Modernization Act (FSMA)’s PCHF rule, training records are required for every employee. The FDA inspector will review your training records as part of a FSMA inspection. Companies earning more than $1,000,000 annually must have a PCQI, and most PCQI will provide a certificate from their training. Going beyond the PCQI, all other employees are qualified individuals, i.e. qualified to do their job. Ensure that your training records are complete, up-to-date, and show how an employee is qualified to do their job.

Your company uses signage.
Show me the sign! We have all seen the sign in the public bathroom stating employees must wash hands before returning to work. I think we get a little numb to the handwashing command. In fact, you cannot invest enough time and resources for proper handwashing. Besides handwashing, we use signs to direct employees to do many things. Signs are great! I am a huge proponent of signs. First, a picture says a thousand words; use pictures on your signs. Make the signs language appropriate for your employees. Use universal symbols as much as possible. Use color. If your employees are getting numb to the signs, move the signs. Change it up. Change the color. Change the shape.

As I travel to different food factories and am escorted into operations, I am always impressed by well-used and maintained handwashing stations, perfectly placed in a transition area and before entering operations. I like to see reminder signs. I love to see posted directions on the proper method for washing hands. My biggest pet peeve with handwashing is people not rinsing and wetting their hands before applying soap. Rinse first! Also, how many of us lather the full length of two “Happy Birthday” songs? That is the minimum time for just the lathering step.

Your company has obvious means for employees to report problems and offer suggestions.
Do you have a suggestion box in the lunchroom? As you observe employees in operations, do they freely discuss concerns with each other and supervisors? There should be an obvious and free exchange of information at all times. A red flag is when an employee is asked a question they should know and states they do not know. Does your company have team meetings with operators? Team meetings should include all shifts and facilitate communication among operators.

I worked with a company where the President sat at the conference table with his Vice Presidents and Managers. Over and over, I witnessed the President shutting down the excuses for food safety shortcomings. He was preaching food safety culture. Sanitation doesn’t have enough thermometers. Buy more. It’s not practical to record data in real time. Find a technology that works in real time. Occasionally a foot foamer is not working. Have a back-up ready to go.

Matthew Botos, CEO of ConnectFood.com, tells us, “Food Safety is ‘Basics Done Well’. As described, risk management best practices start at the top and filter all the way down to every employee and vendor. Food Safety is everyone’s responsibility. There are many tools out there to help companies.”

It is difficult to present a favorable food safety culture and sometimes more difficult to measure. The topic of a food safety culture is new and will develop over time in the food industry. As we continue to talk to each other about food safety culture, we will know it when we see it, and we will be able to measure it.

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

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