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September 18, 2017: Enforcement Date for Food Safety Plans

I am writing this on September 18th, 2017. For over a year I have trained people in workshops that this date is the FDA enforcement date for all food companies as regulated under the Food Safety Modernization Act (FSMA)’s Preventive Controls for Human Food rule. The small companies had more time for compliance, but this is it. Time is up.

Going forward from this day, all food companies in the United States earning more than $1 million in annual revenue must have a written food safety plan. The written food safety plan starts with a written hazard analysis and ends with a written recall plan. The food safety plan must meet the requirements in Subpart C of the Preventive Controls for Human Food rule. Today changes the way I teach, the way FDA enforces, and the way food companies prove food safety.

Even though today is the day, word on the street is that the FDA is a little behind on FSMA inspections. The FDA has done a great job training inspectors, providing guidance, and giving inspectors the tools they need. I hear that FSMA inspections will be more like audits: with the emphasis on review of the food safety plan and employee training records. There will be less time walking the line and more time reviewing monitoring and verification records. That being said, most FDA inspections are still for Good Manufacturing Practices, found in Subpart B of the Preventive Controls for Human Food rule. If your company manufactures a product that has been recalled by a competitor or is known to be under high scrutiny by the FDA, then you should be prepared for an inspection in the near future. If not, you may have more time to prepare.

Are you feeling overwhelmed? Did you find this blog post because your food safety plan is not finished or you feel it is lacking? I do not want you to feel alone or isolated from the resources and help you need. There are plenty of food companies still writing their food safety plans, so you are in good company if yours is not yet complete. You have landed in the right place – let ConnectFood help you get it done!

ConnectFood is a great tool to write your food safety plan. You can choose the free option, which is a good place to start, or you can subscribe for a low, reasonable cost. By subscribing, you will have access to the ConnectFood experts, like ConnectFood CEO Matthew Botos, myself, and other ConnectFood experts. If we don’t have the answer, we have a vast network of food safety experts to get you the answers you need.

Please comment on this blog post below. I love feedback! 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.

How Do I Write a Food Safety Plan?

Congratulations! You are looking for expert help in writing a food safety plan, and you found ConnectFood. ConnectFood developed software for an on-line food safety plan builder with you in mind, every step of the way. You are not alone. Behind the screen there is a cadre of food safety experts to help you. Through our knowledge, experience, and connections, we can help you write your food safety plan quickly. I have known Matthew Botos, CEO of ConnectFood, since 2000. I know Matthew to work tirelessly for the food industry, to travel worldwide for training and helping the food industry, and to network with government agencies from local to federal.

FDA recently published their on-line food safety plan builder for food manufacturers. Like usual, FDA is late to the party and behind industry. I have worked alongside some fine people at FDA. They work hard to steer a huge, government system. Like the Titanic, reaction time is slow and often too late.

ConnectFood has been working with the food industry to write food safety plans for over three years. My biggest concern for companies writing their food safety plans is getting their questions answered in a timely fashion. FDA has a Technical Assistance Network (TAN) which will answer questions on the rule only. Don’t expect an answer within 24 hours. At FDA pace, it would take months to write a single food safety plan. If the question is outside the realm of the rule, companies will be referred to the Food Safety Preventive Controls Alliance (FSPCA) TAN. Matthew, ConnectFood Experts, and I have access to members of the FSPCA TAN too.

Getting questions answered is one of the reasons that a Preventive Controls Qualified Individual (PCQI) is required to supervise the writing of a food safety plan. Do you know who is a PCQI? Matthew Botos, CEO of ConnectFood, and I are. Not only are we PCQIs, but we are also Lead Instructors of the workshop for PCQIs. Matt Botos also is a Trainer of Trainers. Collectively, we have delivered over 50 PCQI workshops since the end of 2015. It is pretty safe to say we know the rule. Matthew is a food engineer, and I am a food microbiologist. Along with our network of food safety experts, ConnectFood has you covered. The ConnectFood software is a cost-effective method to get your food safety plan written. ConnectFood continues to develop cutting-edge easy-to-use software for an on-line food safety plan builder that can be used to showcase food safety either on-line or printed out to be shared with clients or regulators.

ConnectFood is not just for food manufacturing. Restaurants are using the ConnectFood software to build their Hazard Analysis and Critical Control Points (HACCP) plan. While the application is a bit different, the process of building a HACCP plan is the same. ConnectFood is the perfect solution for chefs and our foodservice friends: restaurant food safety could look like HACCP, the important part is to know your product, ask yourself if you have any hazards, and have a good safety plan!.

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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I am a Preventive Controls Qualified Individual – what now?

I am a Preventive Controls Qualified Individual (PCQI). What have I gotten myself into?

First, congratulations! You have taken a big step in preventing hazards and providing a safe food for your customers. When teaching the PCQI course, we emphasize four major responsibilities of the PCQI:

  1. Create and implement the food safety plan
  2. Validate preventive controls in processing and potentially for allergens and sanitation
  3. Review records
  4. Reanalyze the food safety plan

As you can see these are large areas filled with details. Much of the work of a PCQI is focused on getting the food safety plan written, including the recall plan. You are going to do this in a team. It works better in a team. You can delegate. Reach out to personnel who you do not routinely work with, like human resources, sales, purchasing and transportation. I encourage my workshop participants to let go and let others do the work. As PCQI, you have to oversee the writing, but you do not have to do the writing. Find that super-organized person in your company, and have them do the organizing of materials and reminding others of deadlines set by the team. We all have that person who loves to tell others what to do. Put the full authority of the PCQI behind that person and unleash him or her.

Your day-to-day and week-to-week operations may not change much from what you do now. You will find steps where there is control of a hazard and document that. Much of this is done and already being done. In your hazards analysis, you identify process, sanitation, allergen and/or supply chain preventive controls, their corrective actions or corrections, and record keeping. You may identify hazards that were not previously identified and documented, but that work will just become part of your food safety system and part of your daily and weekly work along with what you have been doing.

Each PCQI works in a different food factory with different ingredients, equipment and products. Some factories have been operating the same way for decades and foresee no changes. Some factories are brand new. Some factories are expanding and bringing in new lines and their equipment. The food safety plan must be reanalyzed every three years, if there is no reason to do so earlier. Earlier reanalysis is at least discussed at the identification of a new hazard, new supplier, new equipment, new product… You get the picture. Any time there is a change in the food safety system, you as PCQI will document that you addressed the hazard potential and either changed the food safety plan or decided the current food safety plan controlled the hazard. The key to your success is documentation, but you already knew that!

Dr. Kathy Knutson 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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Training Basics for Preventive Controls Qualified Individual

Training of Preventive Controls Qualified Individual (PCQI): the Basics

Who trains PCQIs? Lead Instructors (LIs). LIs come from industry, academia, government, professional and trade associations, or are independent consultants like me. All LIs are PCQIs and attended a workshop using the FDA-recognized curriculum. There are hundreds of us. In the same way PCQIs are being tracked by the International Food Protection Training Institute (IFPTI), there is a list of LIs. My guess is that half of LIs are in industry, teaching privately within their company. Think of very large companies and the need for internal training of PCQIs. Corporate LIs are getting people at each of their plants trained as PCQIs.

Professional and trade associations offer either private or public workshops. If you are in a specific field like produce (pun intended), dairy, bakery, or others, it may be beneficial for you to attend a PCQI workshop with an association serving your industry. You can go to the association website to look for training offerings. The other option when seeking a workshop is the list on the Food Safety Preventive Controls Alliance (FSPCA) website. In order for PCQIs to receive a certificate from IFPTI and FSPCA, the workshop is registered with IFPTI. You can search by course, course start date or location, with a link to registration. Go to the following page and click on FSPCA Preventive Controls for Human Food Courses under RESOURCES:

https://www.ifsh.iit.edu/fspca/fspca-preventive-controls-human-food

or directly here might work: https://fspca.force.com/FSPCA/s/course_registration/Course_Registration__c/00B36000007edjpEAA

I just spent some time navigating the list, and it is frustrating. Hang in there! FSPCA updated their website, and it is not for the better on the course listing page. At this point, there is a PCQI workshop every business day somewhere in the world. As consultants, Matt Botos, ConnectFood CEO, and I teach both private and public workshops and are willing to travel almost anywhere in the world. Matt was sent to Kingston, Jamaica when other LIs refused to go. That’s our Matt!

Over 18,000 PCQIs have been trained using the FDA-recognized curriculum. Some are the sole PCQI at their facility. Other companies have sent waves of personnel to get trained and stacked their departments with multiple PCQIs. Even expert food safety consultants have gone through the training to receive the title of PCQI. No matter where they come from, all PCQIs have been trained with the same curriculum.

Every PCQI receives the same book and training from the same deck of PowerPoint slides. I have been trained to write curriculum at the high school and college level. The curriculum is practically perfect in presenting information in 16 chapters, each starting with objectives, then material, chapter summary and additional reading resources. The book is packed with information and used by PCQIs as the bible of food safety. PowerPoint slides, worksheets and model food safety plans are all provided. As a LI, I add my personal stories and can supplement my own slides or handouts into the presentation.

There is only one recognized curriculum. It involves 20 hours of training. A typical public workshop is two-and-one-half days. Private workshops can be designed any way you want. If you want to do ten weeks of two-hour training sessions, that works! Five, four-hour sessions work. The requirement is to cover all the material, and participants must be present at all times. There are training companies offering workshops with their own curriculum and materials which are not recognized by FDA. If a workshop is not registered with IFPTI, the participants will not receive a certificate from IFPTI and FSPCA. Receiving a certificate from a different organization does not meet the requirement in the Preventive Controls for Human Food rule and will not be recognized by FDA. There are no on-line workshops at this time recognized by FDA. Buyer beware!

Matthew Botos and I welcome your questions about training.

Dr. Kathy Knutson 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.