Category: Food Safety 101

Audit Case Study: The Value of a Food Safety Consultant 

Third-party audits are one of the tools used to keep our food supply safe and inspected. Larger stores and distributors often require proof of a third-party audit as part of their wholesale purchasing agreements. Therefore, as your food business grows, you need to be prepared to get one. A third-party audit is an audit conducted by an independent organization not affiliated with either the seller or the purchaser of the food item (For more information on audits, check out this blog post). The purpose of the third-party audit is to get an unbiased assessment and verification of the safety and quality of food production.  Third-party audits are nothing to be afraid of if your food safety program is up-to-date and comprehensive. However, many businesses are lacking crucial documentation of processes which can make the audit process far more stressful. In this case-study, we’ll look at the journey of a client who found themselves in a predicament when asked for a third-party audit. We’ll explore how Food Safety Mid Atlantic is helping them overcome the hurdles and get their program set up.  The Initial Dilemma: The Request for a Third-Party Audit Our client, a small food business, had been selling to Whole Foods for several years without needing a third-party audit. However, once Amazon acquired Whole Foods, they were asked to provide one.  The client had no audit on hand, nor did they have documentation of processes required to do an audit. They knew that to keep selling to Whole Foods; they needed to develop a comprehensive food safety program and obtain the audit. First, the client reached out to several auditing bodies to find out what the audit would include and how much it would cost. They were given a fixed price of several thousand dollars for the audit alone, plus an additional three times that cost for the templates to create their SOPs and GMPs. This price covered only the templates, not support for filling them out.  This exorbitant cost and lack of support dismayed our client.  Reaching Out for Assistance and Preparing for the Audit Fortunately, before committing to a high cost program with limited support, the client remembered meeting Cathy at a conference. They reached out to Food Safety Mid Atlantic, and we were happy to help.  First, we conducted a GAP analysis of the business, which essentially served as a self-audit to identify the gaps and shortcomings in the client’s food safety practices.  After the GAP analysis, we sat down with the client and discussed what to focus on and how best to proceed. They needed written processes and procedures and a way to log data. Since this was an established business, we recommend that they immediately begin using a food safety software such as Food Ready to keep track of their paperwork and logs. For newer businesses, we would start with a collection of Google Documents and Sheets.  We advised the client to inform Whole Foods and their distributors that they had begun developing and implementing the food safety program needed to get the audit. This transparency and commitment to improvement were well-received by all parties involved because the client could show they were working with a food safety consultant. Challenges Faced: Time and Financial Considerations Though the client is now in the beginning stages of getting their paperwork together, creating a documented food safety program, and eventually getting the audit, it has not been what they expected.  There is substantial time and money required to have a strong food safety program. Our client was originally given 180 days to prepare for their audit. Even assuming a written plan and a full-time food safety person, that would be a tight turnaround. Given where our client is starting from and the fractional services from Food Safety Mid Atlantic, we are expecting the process to take closer to eighteen months.  Food safety doesn’t come cheap. There is a high audit fee in addition to the cost of preparing all the documentation. Our client is relatively well established, but even small start-up companies end up paying thousands of dollars to set up their food safety programs. If you’re considering starting, or expanding a business, be sure to budget more than you expect for food safety costs.  The Value of A Food Safety Consultant A solid, documented food safety program is the backbone of a food business, especially once you begin selling to major retailers. It’s necessary for getting your third-party audit, and for producing high-quality, consistent products.  As the case study above shows, having the support and guidance of a food safety consultant helps you navigate the complexities of building your program and obtaining your audit. The consultant can assist you to conduct a self-audit, identify areas for improvement, and create your food safety program. Being able to show evidence of your consultant also helps you maintain the trust of the retailers and distributors that purchase from you.  If you are in the same position of the client above and you need to build up your food safety program, create SOPs and GMPs, or prepare for an audit, we are here to help. 

Food Safety Self Audits Are Essential for a Safe Food Business 

A food safety self audit is the best way to prepare for a food safety inspection or third-party audit. It’s better to catch issues yourself and fix them on your own time, instead of an inspector catching them and causing a plant shutdown or recall.  Food safety self audits follow the same pattern as food safety inspections, but the person reviewing your food safety plans and procedures is you or an employee. While you can (and should) do a self audit to prepare for an external inspection, it’s also a good practice to regularly schedule self audits to make sure that your food safety processes are being carried out correctly. In this blog post we’ll cover what a food safety self audit is, how to conduct a self audit, and why you must consider scheduling a self-audit as soon as possible.  What is a Food Safety Self Audit? A food safety self audit is an internal inspection of all food safety processes and procedures. It reviews the same elements of a food safety inspection or third-party audit with much lower stakes. A food safety self audit allows you to identify holes in your food safety program and patch them before they cause harm to your business. A self audit is an opportunity to make sure your paperwork is in order and your processes align with your written plans.   There are two types of self audits: paperwork or desktop audits and on-site or facility audits.  Paperwork audits review your food safety plans and record keeping. During a paperwork self audit you review all SOPs, SSOPs, and GMPs and make sure they are up to date. You check your HACCP or Food Safety Plan for errors or inconsistencies. You review your records to make sure they are being well kept and verified every seven days.  On-site audits review your physical space and the food safety procedures that occur in your facility. During the audit, you look at everything from employee hygiene to HACCP control points to sanitation and maintenance. The on-site audit should include everything that happens every day from when employees arrive until the sanitation crew clock out late at night, and every part of production from ingredient arrival to shipping your final product.  How to Conduct a Food Safety Self Audit The first step in conducting a food safety self audit is to define the scope of the audit. Are you:  Understanding your motivation for the audit allows you to determine what and how to audit. Find or create a checklist to follow for your internal audit. This will ensure you don’t miss anything when conducting the self-audit.  If you’re preparing for a federal or state or local inspection, get a copy of the inspection document. This tells you what the inspector will look for. Copies of most third-party audits are available from the auditing body.  If you’re just inspecting for internal review, decide which areas of your food safety program are your top priority.  Choose an individual to conduct the audit. This might be yourself or your facility manager. Make sure this person is knowledgeable about your food business’s food safety program and can tell whether it’s being followed.  Decide if you are doing a paperwork or an on-site audit, or both. Since you’re doing the audit on your own time, there is no need to rush the audit or cram everything into one day. You can space it out to make sure it fits in with the rest of your work.  Paperwork audit Find your paperwork and make sure it’s accessible. Doing this first during an internal audit will mean it happens smoothly during an external one.  Review the paperwork that fits within the audit. You could review everything or you could choose to only focus on something specific such as maintenance records and SOPS, inventory record keeping, or allergen tracking.  Keep in mind that the paperwork for paperwork audits does not need to be physical paper. Computer-based digital records and SOPs are acceptable.  Onsite audit Determine the scope of the audit. It’s challenging to inspect every single element of your facility and processes at once, so it’s best to focus on specific elements such as whether employees are following GMPs by wearing hairnets and closed-toe shoes and washing their hands or whether all the lights in the building work.  Follow your self audit checklist to make sure that you inspect everything. Once you finish the inspection, review the checklist and make a list of all areas for improvement. Notify all relevant personnel about the problems so that they can fix them before the next inspection.  Scheduling Your Self Audit Most third-party audits expect food businesses to carry out a self-audit annually. Thus, when you are planning and developing your food safety program, add self audits as a regular practice.  Now is the time to start, if you already have a food safety program and aren’t doing audits.  If you need help to prepare for your next inspection or implementing regular self audits, schedule a free consultation with Food Safety Mid Atlantic today.

Food Allergy Tips – Protect your Customers and Your Business

Food allergies are a major factor in the lives of millions of Americans. Allergic reactions range from minor discomfort to full anaphylaxis. There are over 170 foods that have been identified as causing allergic reactions, but the majority of reactions come from the Big Nine: milk, eggs, nuts, fish, crustaceans, shellfish, wheat, soy and sesame. For many years, there were only eight major allergens identified by the FDA. Sesame was added to the list on January 1, 2023. If any of these nine allergens is in a product, even in trace amounts, it must, by federal law, be identified on the food label. In this blog post, we’ll cover why it’s important to protect consumers and your business with allergen labeling, the hidden spots where allergens may be found, and the food safety practices you can implement to protect people with allergies.  Why label allergens? Though allergens are only dangerous to the person sensitive to the allergen, for those people they can be deadly. The only way allergy sufferers can be safe is to avoid their triggers. Clear product labels help allergy sufferers find which foods they can consume safely. One of the main ways food manufacturers keep people with allergies safe is through allergen labeling. The FDA’s Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 established the original eight food allergens with the requirement that they must be identified on food labels.  When food allergens are on a food label, it’s easier for individuals with food allergies and their caregivers to identify which foods are safe to eat. Thus, labeling creates consumer trust and allows people with allergies to live with less fear of accidentally consuming the allergen. However, a third of FDA food recalls are due to allergens not listed on the label. Labeling allergens is particularly valuable in instances where the allergen is a minor component of an ingredient or may not be expected in the product. For example, milk may be present in chocolate chips. Sesame can be present in granola or crackers. And, you might find eggs in soups or soup mixes. Creating An Allergen-Aware Food Safety Program If you produce a product that contains a food allergen, especially one of the Big Nine, it’s imperative that your food safety plans and practices include protocols for managing allergens in your facility and production process.  You need an allergen control program which includes specific Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) for every step of the production process involving allergens. Make sure to include: Allergens frequently get into food through cross contact with equipment, the movement of individuals throughout your facility, and the flow of air in your space. Airborne allergens are a real risk. It may be worthwhile to ban certain allergens from your facility if you are making an allergen-free product.  The risk of mislabeling allergens or having an unlabeled product is two-fold. You could cause harm to a person with an allergy and you could cause harm to your business. Mislabeled or unlabeled foods will need to be recalled and can lead to a loss of consumer trust; both of which  could put a small food business out of business.  The best way to support your consumers with food allergies and prevent a costly recall is to have a comprehensive allergen policy. If your allergen policy needs a refresh to account for sesame or you never had one to start with, schedule a free consultation to get the process started. 

Don’t Be Scared of A Food Safety Inspection: How to Prepare and What to Do

As a food business, you likely get a regular food safety inspection done by your state or county and by the FDA.  We know that these inspections can feel daunting. But, they don’t need to cause anxiety. With proper preparation, they’re an opportunity to improve your food safety practices . We all share the goal of safe food and safe production. During a food safety inspection, you get to assess your food safety program and identify areas for improvement. With a mindset of collaboration, the inspection becomes a tool.  In this blog post, we’ll cover what an inspection is, how to prepare for future inspections, and what to do on the day of for best results.  What is a Food Safety Inspection? A food safety inspection is a review of your food safety plans and the ways they are being carried out day to day. The FDA does inspections, as do local and state governments.  There are two types of inspections: Most inspections combine a desktop inspection and an on-site inspection. This comprehensive inspection will focus on the following areas: A food safety inspection can occur at any time during regular business hours and without advance warning. However, if you have a good food safety plan in place and always follow it, the inspection should be nothing to worry about.  Preparing for a Food Safety Inspection The best way to prepare for a food safety inspection is to carry out an internal audit. Review your food safety plans and procedures to make sure that the day-to-day operations of the business align with the written plans.  If possible, try to get a copy of the inspection form or the guidelines that inspectors must follow. When you do your audit, follow the same guidelines to ensure your business is in compliance.  Communicate with your employees about inspections before one occurs. Make sure that everyone knows what an inspection is, what to expect, and how to behave. The inspector will ask employees questions so they must be knowledgeable about your food safety program. Create a plan for what will occur during the inspection. Choose specific individuals to walk with the inspector and take notes. Make sure that all records are in an easily accessible location and are up to date.  With a plan in place, you’ll be able to take the inspection in stride rather than panicking when the inspector arrives. What To Do During a Food Safety Inspection  When a food safety inspector arrives, immediately activate your inspection action plan.  Generally the inspector will want to review your documents before the on-site inspection. Bring them first to a quiet space where they can review the documents. Remember that the inspector is a visitor and should follow your visitor policy. Have them sign in, remove jewelry, put on a smock or hair net, and do any other protocols.  Then accompany the inspector as they do the inspection.  Don’t argue with the inspector while they are conducting the inspection. Note any problems. If possible, correct any errors during the inspection. For example, if someone isn’t wearing a hairnet, have them put one on. Ask the inspector lots of questions. The inspector is an expert in food safety and has the same end goal as you. Let them help you make your food production as safe as possible.  At the end of the inspection, get the written report from the inspector and make plans for improvement. Continue to build a positive working relationship with the inspector. They can help you correct any errors and strengthen your food safety program.  Ultimately, food safety inspections are an opportunity to check that your food production process is safe. While an inspection can feel terrifying and could shut your operation down, we like to assume that you’re doing a good job. In fact, you’ll likely benefit from an external check on your food safety plans and processes.  The best way to get the most out of your food safety inspection is to be prepared. About a month before you know you’re due for inspection, do that internal audit to identify weaknesses. This will show that you’re working on correcting them. If you want external support with your audit, schedule a free consultation today to see how Food Safety Mid Atlantic can get you ready for inspection. 

Start with the FDA Good Manufacturing Practices to Build a Strong Food Safety Plan

Having a good food safety program is key to food business success. Yet, it’s hard to know where to start with creating your plans and documents. The FDA’s Good Manufacturing Practices (GMPs) are a set of standards that regulate food safety. They serve as a model for creating a successful food safety plan.  The GMPs are not comprehensive, but they identify key risks that may exist in your process and show how you and your team can control them.  Beyond their value in shaping food safety plans, GMPs are regulated and inspected by the FDA. Even if you are a small producer, the FDA can inspect you on your GMPs. Therefore, it’s extra important that your food safety processes are in compliance. The GMPs contain five main areas of focus. In this blog post, we will discuss those areas and their importance, and share the value of GMPs for your food safety plan overall.  Good Manufacturing Practices 5 Areas of Focus The FDA has organized the Good Manufacturing Practices into five areas of focus. These areas each address a part of the food production and storage process. The overall goal of the GMPs is to keep hazards out of the finished product.  Designing a food safety plan that addresses each of these areas of focus will ensure you are adhering to the GMPs. It will also guarantee that you are keeping your product as food safe as possible. These are the five areas of focus covered in the FDA GMPs: 1. General Provisions  This section outlines the expectations for people who produce the food. It outlines the responsibilities of the business owners and management regarding when people can be allowed to work after illness. It also details personal hygiene requirements and the expectations around food safety training.  Example from the GMP regulations: Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food 2. Buildings and Facilities This section contains requirements for the physical space where the food is produced. It includes expectations around the layout, facilities, and cleaning practices necessary to ensure a safe environment.  Example from the GMP regulations: The plant and facilities shall: Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.  3. Equipment  This section explains the expectations around keeping equipment safe and sanitary. In particular, it covers controls for regulating temperatures and notifying employees if they fluctuate too much.  Example from the GMP regulations: Seams on food-contact surfaces shall be smoothly bonded or maintained to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. 4. Production and Process Controls This section discusses the sanitation processes that need to be in place to keep food safe. It also covers how to prevent contamination during post-production storage and distribution.  Example from the GMP regulations: Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act.  5. Defect Action Levels  This section acknowledges that sometimes foods that are produced safely still contain low levels of natural or unavoidable defects that are not hazardous to health. It defines the maximum allowed levels of defects such as insects, rodent filth, and mold. The FDA still expects these levels to be as low as possible and provides guidance on how to manage them.  Example from the GMP regulations: The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food. Together, these focus areas show how to safely operate a food safe production facility. For more information about the specifics contained within each of the focus areas, refer to this FDA resource.  Why the Good Manufacturing Practices are Valuable The Good Manufacturing Practices are an invaluable tool for food safety, both for new processors and existing food facilities.  If you are just starting to produce at scale, the GMPs are a great template for creating a food safety plan. Make sure you cover all the areas discussed above to give you a strong, comprehensive food safety plan.  If you have an SOP that documents how you will carry out each process, you will be in compliance with the regulations. In particular, the GMPs are valuable because they cover personnel requirements and detail what to do in the case of bacteria cross contamination and allergen cross contact. Most bacterial and viral food contamination is caused by the people making the food. The GMP guidance on personal health and hygiene, and instructions on behavior help you control that risk.  Cross contact is a big issue for allergens. Nearly a third of food recalls are because an allergen was not listed on the label. The GMPs clearly outline how to prevent cross contact between allergens and what to do if an allergen gets into a food. If you can catch this before the allergen ends up in the final product, you save on the cost of having a recall due to misbranding and you protect your consumer.  It’s important to show buyers and auditors you are continually improving your food safety program. Thus, even established businesses with great