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

With formidable GMPs, you lay the foundation for HACCP and Food Safety.

When the FDA or state inspector steps inside your facility, they may not want to immediately go to a conference room and review your written Hazard Analysis and Critical Control Points (HACCP) or food safety plan. The written plan is important, but the inspector will potentially want to walk the facility for a current Good Manufacturing Practices (GMPs) inspection. There will be inspection checklists and notes of observations. Shortcomings could result in a Form FDA-483 to the facility from the inspector. Companies should continue to work hard on their risk management programs and that starts with the food safety fundamentals of GMPs.

In the same way that you can’t run a business without funds, people, equipment and supplies, you can’t have a functioning HACCP or food safety plan without a foundation of good current GMPs.

Lynn Knipe of Ohio State University said it well,

    GMPs can support a processors’ HACCP programs, however, they cannot be used to directly control a hazard.

As I work with clients on HACCP or food safety plans, I have been reminded several times this week of the importance of GMPs in my work, which brings me to write about GMPs again. In a previous post, I wrote a review of GMPs on ConnectFood.com. When I reviewed the weekly post of FDA Warning Letters for food issues, I found mostly GMP issues, not HACCP or preventive controls issues. In most cases, a food facility receives an Warning Letter as a follow up to an inspection and Form 483, when the FDA is not satisfied with the actions taken to address the issues. Sometimes it is a matter of timeliness in that the facility has not responded by a deadline or is lacking documentation to prove corrective action. Warning Letters can be juicy reading for those of us that live food safety and for customers and clients because they are very specific in naming the issue.

Let’s play a game of “Name the GMP that was not followed.”

Case study: Cakes and Biscotti Bakery

    [a] live rodent was observed running across the east end of the production area, into the laundry room and into a hole in the wall at the northeast corner of the room.

Name the GMP that was not followed: Pest Management & Plant and Grounds

    [d]ough residues were observed on the edge of the (b)(4) north prep station and on the (b)(4) south prep station after (b)(4) sanitation was conducted.

Name the GMP that was not followed: Sanitary Operations

    [t]he interior of the stove hood was observed with a build-up of dust and debris directly above the stove and prep table where uncovered in-process foods are prepared. Employees were observed melting chocolate and gelatin, heating cream, and preparing blueberry topping on the stove directly below the hood.

Name the GMP that was not followed: Plants and Grounds

    [i]n the men’s restroom, the floor was observed soiled in front of both toilets, the urinal, and both sinks. One of the toilets was observed soiled. A toilet brush was observed on the hand wash sink. No hot water was available at the hand wash sinks and no paper towels or hand drying device were observed. The trash can was observed with overflowing toilet paper tubes, used paper towels, and other waste.

Name the GMP that was not followed: Sanitary Facilities and Controls

    [a]n employee was observed handling biscotti with a bare hand that was bandaged. She was observed removing the bandage and continuing to package biscotti without washing her hands.

Name the GMP that was not followed: Personnel

In the latter example, there are so many problems to address. Because of the bandaged hand, the employee should be removed from the packaging station. Without the need for a bandage, the employee should be following hand washing procedures and the glove use policy. This observation shows a lack of food safety culture and the need to train the entire workforce at packaging.

This food safety culture is key. Being part of the team in the position of writing a HACCP or food safety plan, please take time for an internal audit of GMPs. Without good GMPs, food safety cannot be realized. The search for GMP forms and checklists can be overwhelming, and the ConnectFood website has free resources. Sign in and find information under cGMPs. Do you have questions about GMPs? 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

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