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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.

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

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