Tag Archive for: audit

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Logs & Record Keeping

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.

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If I Am Compliant with a Third-Party Audit, Am I FSMA-Compliant?

One of the biggest challenges for a company and its Preventive Controls Qualified Individual (PCQI) is organizing both the food safety plan and materials for an audit. The food safety plan will be reviewed by the local, state, or FDA inspector. Some companies are under USDA inspection as well. In my experience, most food companies have a third-party audit for BRC, SQF, or ISO 22000 certification or with an auditing firm specializing in food manufacturing. How do you prepare for both?

There are different requirements for a government inspection and a third-party audit. The inspection is driven by public health and regulations. Food facilities will be inspected against the requirements for Good Manufacturing Practices, hazard analysis, preventive controls, and recall plan found in the Preventive Controls for Human Food rule. Quite frankly, the government is not concerned at all with your audit criteria. The focus will be on public health and FSMA rules. Going forward, FDA inspections will evolve in to more audit-like activities with the emphasis on record review. The PCQI is required to organize or oversee the organization of records. The goal is to be inspection-ready at all times.

Much of the material that is required for an audit is the same for an inspection. Each certification or auditing body has their own requirements, and often the PCQI has the responsibility of organizing these materials also. Do you need help with organization? I encourage PCQIs whom I train to find that one person at work who loves office supplies. Put them in charge of labeling and storing materials. Trust me, they will love it! Also, find the person who is exceptionally good at organizing electronic documents. Put them in charge of developing the system of storage and retrieval. The PCQI just needs to know where paper and electronic files are and how to access them.

Do you remember Venn diagrams? List everything you need for an inspection in one circle. List everything you need for an audit in a second circle. What overlaps, and what is unique? One option is duplicating common records for both inspection and for auditing. Another option is to keep records unique to an inspection separate from records unique to an audit and have one record of common records. The inspector will not review records unique to an audit. As you are working through this organization, focus on the best location for individual records, in general. Records for an inspection can be paper or electronic, in a format of your choice. There is no mandate for use of forms. Focus on what makes sense for storage and then retrieval of records.

Let’s go back to the original question. If I am compliant with a third-party audit, am I FSMA-compliant? Maybe; it depends. The Preventive Controls for Human Food rule requires a written hazards analysis which identifies hazards requiring a preventive control. The preventive controls go beyond process preventive controls to include allergen, sanitation, and supply chain preventive controls. If all the preventive controls are addressed in the audit requirements, then you are covered for both an inspection and audit. Beyond the Human Food rule, are you compliant with the Sanitary Transportation rule? In 2019, compliance with the Intentional Adulteration rule takes effect. Are you required to comply with any of the other FSMA rules? The answer is complicated.

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

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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