When writing Good Manufacturing Practises, my first stop is to check out the FDA’s guidance documents. These documents provide helpful advice as, while they not legally binding, they explain FDA’s current thinking on a topic to do with food regulations or dietary supplements. Specific regulatory or statutory requirements are cited within the documents.
The topics covered by different documents span from food safety to food labelling, from milk guidance to medical foods, there is a wealth of information on current thinking there. For example, there is a draft guidance for the “Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” which gives recommendations to covered farms on the thought of current practices for produce. The topics covered in this guidance document include how to tell if your farm is a covered farm, hygiene practices, recommendations on practices for safe growing, harvesting, packing, and holding activities on your farm etc.
Once you have decided on the topic of the particular GMP you need to write, you can start your draft using language from the relevant guidance document. There may be another way to do the GMP you are writing about. However, be prepared to defend its effectiveness if you are not following FDA’s recommendations. Especially if it is part of your food safety system to reduce pathogens.
MUST means that this part of your policy will always happen; usually because it is in the regulations. In your own GMPs you can decide that something has to happen that isn’t required by law and it becomes a MUST statement. For example, the farmer MUST provide handwashing facilities at all field sites.
Should means that something is recommended, but not required by the regulations. For example, farms that do not fit the category of covered farm, SHOULD still follow federal regulations and have a prerequisite program in place.
Including means options that are not limited to the described items. For example, processing methods that are approved to treat produce after harvest that reduce the growth of pathogenic bacteria INCLUDE making jams and jellies, cooling freezing, adding acid and heating.
Once you have written a GMP, you must write a Standard Operating Procedure for each key step especially if records are necessary to verify that the procedure took place. You must also have a system in place where someone else further verifies that the procedure was carried out as described by the SOPS. My personal policy is that, at a minimum, you want an SOP for every form that must be completed. I gave details on writing SOPS here.
Do you have GMPS? Not sure they are satisfactory? Finding the language used hard to follow? Consider attending my Food Safety Coaching Workshop in Philadelphia on Aug 22.
Calling all Philly area food artisans and entrepreneurs. If you are a small food business owner, whether a farmer, baker, brewer, cheesemaker, food handler, packer, or processor, understanding and practicing food safety is critical and required for your business. However, developing a food safety plan for your operation can be daunting. At this 6 hour clinic we will demystify the prerequisite programs required for state and federal food safety regulations that affect your business, define key terms, and gain hands-on experience writing Good Manufacturing Practices (GMPs), and creating simple to follow and easy to train Standard Operating Procedures (SOPs) and Sanitation SOPs (SSOPs). Course recommended for owners and employees.
At the end of this course you will have:
Knowledge of the federal regulations
Access to resources on GMPs, SOPs and SSOPs
Templates for SOPs and SSOPs
Your own draft SOP written with expert advice
Continued access to materials on Google drive for 6 months after the course
Class limited to 15 participants
Laptops required. There will be no printed materials.
Instructor: Cathy Davies has over 20 years of expertise as a food scientist. As well as teaching and answering questions about food safety and shelf life, she started her own consulting business, the Food Industry Employment Program, with the mission to assist small scale food businesses with food safety. She writes their food safety plans and checks that her clients are both compliant with food safety regulations and are making a safe food product.
Location: Primal Supply Warehouse in the Philly neighbourhood of Brewerytown
Scholarships available on request
Discount (on request) of $20 if contributing food for lunch
You are making the best food product ever – the best chocolate, the best ice cream, the best pasta sauce; you’ve won prizes at the state fair and your friends tell you how wonderful it is and ask for the recipe and then they never can make it the way you do. So you decided you want to make it on a bigger scale than just for friends and you contact the local health department and they ask you what you are doing to make sure your food is safe; so that there aren’t any bacteria or viruses or parasites or other hazards in your food that would make people sick.
Having read my article of prerequisite programs and my article on GMPs; OH! And the article on which food safety plan you need [you have read them right?], you feel pretty clued up on food safety and you share a few things that you’ve learned and then the health inspector (in my head the inspector always speaks with the voice of doom) asks:
Health Inspector (HI): How you measuring temperature in your product?
You (phew easy answer): with a thermometer
HI: Is the thermometer calibrated?
You: Uh, I check it in ice every morning???
HI: Good. Do you have records of this?
HI: And you’ve written instructions on how you calibrate the thermometer and measure the temperature of your product?
You: I have the instruction manual [thinks “don’t 1? Somewhere?”]
HI: Do you know what a standard operating procedure is?
It is really importantwhen you make a product, and probably the one thing small food businesses are missing the most, is to have records of everything you do. Records of receiving ingredients, records of cleaning and sanitizing the sink, records of training employees to wash their hands, records of weighing out ingredients, records of which batch of ingredients you used, records of…
Hopefully you get the picture.
Yes, it is A LOT of paperwork. A ton of paperwork and I know you would rather be making your food product. While there are computer programs available that will do this from a tablet or smartphone, it is easier to use a spreadsheet to start with.
For every form you fill out, you need instructions on how to complete the form accurately and what to do if the numbers are not within your specs. These instructions are standard operating procedures or SOPs for short. They are similar to lab instructions (remember those from High School or University science classes?). All of your SOPs should have a similar format. I recommended:
Who is Responsible
Procedure (How to do the task)
You also need to make it clear the date the document was approved and what version of the document this is. I’ll do several posts on document control later.
The trick is to make the procedure as simple and clear as possible. Aim for an eighth grade reading level. That way you can use your SOPs for training and leave tasks for your employees to do. Of course, you should check up on them regularly – that’s called verification in FDA-speak.
Questions? Do you have a procedure you want checking over? Contact me so I can take a look and then we can chat.
Before you can start writing procedures, you need to put together policies for the different areas of your production system. As I wrote in an earlier post:
“The policies are known as Good Manufacturing Practices (GMPs) and form the core of your everyday processes. GMPs including receiving ingredients, making product, sanitizing dishes, storage of materials. You, almost definitely, have GMPs now; however they are in your head. not on paper. So it is hard to tell what you have done and even harder for someone else to follow your instructions.”
For large food manufacturers the FDA has more information but this can be pretty overwhelming when you start out. Your policies should align with those listed in 21 CFR 117 subpart B. However, you may have different ways of implementing these policies. If you rent space in a shared kitchen, you might not have to worry about facilities or pest control; even though you will want to make sure that your facility management is doing this for you.
Routine policies that govern your whole facility are part of your GMPS. For example, you may have a trash policy that says all trash will be removed at the end of the day and placed in the dumpster outside. This isn’t a procedure; we’ll get into Standard Operating Procedures in a later post. As this policy covers the whole facility you and your co-manufacturers should write facility GMPs together. For example, you should all agree to a policy of emptying the bins every night.
Resource allocation can be designated through the use of GMPs as using these may show you where there are gaps in your resources and when you need to improve facilities. For example, if you find that people aren’t emptying the trash bins because the dumpster is full by the end of the day, you can decide if you need to increase the number of dumpsters at your facility.
You can use GMPs to control how to manufacture your product. Once you know the hazards of your manufacturing process, GMPs will state how you are going to monitor and/or control the hazard. By having such a policy, you can be consistent whoever is carrying out the procedure. For example, if you measure the temperature of your product, you must have a thermometer policy which explains what thermometer to use when, how and when thermometers are checked, how and where thermometers are stored, and how often thermometers are sent for calibration.
Having a good GMP system in place lays the foundation of your prerequisite program. From this you can write SOPs and SSOPs to make sure the practices are carried out accurately and appropriately.
Write in the comments below one GMP policy you are struggling to write and would like some help with.
We talked previously about food safety and discussed which food safety plan you must have. Before you can implement either a HACCP or a FSMA food safety plan, you need to make sure that you have your prerequisite program in place. These policies, procedures, and records are essential If you want to avoid making people ill and act as the core of your food safety plan.
Ready for your inspection? Where are your records? Do have your policies in place? Training a new employee? How can you make sure that every process is followed exactly? What are your sanitation practices
The policies are known as Good Manufacturing Practices (GMPs) and form the core of your everyday processes. GMPs including receiving ingredients, making product, sanitizing dishes, storage of materials. You, almost definitely, have GMPs now; however they are in your head. not on paper. So it is hard to tell what you have done and even harder for someone else to follow your instructions.
If you do any record keeping, every form you fill out MUST have a standard operating procedure (SOP) to explain how to do the task being recorded. SOPs are also important for processes that must be followed even if there isn’t a form to show that it is done.
If you clean and sanitize, which I hope you are, you need to have Sanitation Standard Operating Procedures (SSOPS) so that every time someone is cleaning and sanitation they do it the same as everyone else.
You need prerequisite programs every time you check the labels you put on your food products, You need prerequisite programs each time you have a visitor into your facility.
You need a prerequisite program to show how you are measuring temperature for your critical control points or your preventive control.
You need a prerequisite program to implement your food safety plan.
Do you have a prerequisite program? No time to implement a prerequisite program? Need to know more about what a prerequisite program contains? Contact me!
Close your eyes and remember the first time you ate a fresh strawberry or a ripe peach.
Imagine the juices dripping down your chin as you bit into a slice of watermelon.
Think about eating a tasty, crumbly, creamy cheese.
Or perhaps you remember the aroma of a juicy steak just off the grill.
Just writing this makes me feel privileged to have had those experiences. I traveled through most of Europe, eating as I go. The memories of eating a baguette with cheese in Paris, a meat tray on a wooden platter in Austria, fresh watermelon on the beach in Croatia after snorkelling, fresh pasta in Rome while eating with friends and colleagues will never leave me..
I have also been fortunate to have grown my own food – mostly vegetables, and some soft fruit. There is nothing that can replace going into my garden on a cool dewy morning to pick full ripe blackberries or eating fresh cherry tomatoes straight off the vine. My mum used to rave about my red cabbages – because they were straight out of the ground they tasted nothing like those from a supermarket.
There should be no privilege in enjoying food. We all must have the opportunity to experience food as joy. I was going to call this blog post “Food as a Weapon” and start listing the ways in which food is used to control and oppress people. I just attended a couple of conferences and webinars where the use of food as a weapon was clearly the goal of many governments and lead to hunger and starvation in, for example, Yemen, Syria, and Venezuela. Even without direct government involvement, political decisions in the US and in Europe mean that for some people just getting any food is a hassle removing all the pleasure out of eating. People should not have to worry whether their food is safe and healthy to eat at every mouthful. I might still write that blog post one day.
Today, I want to remember the pleasures of eating good, healthy food. Let us never forget what that joy tastes like.We must appreciate and remember those moments of joy and make sure that we all have the opportunity to create them again and again. Do not take for granted the food on our plates and do not forget that joy because, if we do, we will lose it. Currently we have two different food systems: One for those who can afford fresh, organically grown, local food and the other for people who can only afford mass produced packaged food-like substances.
Share a joyful food memory in the comments and directly share the joy of food with a friend or a family member this month. Find a local food artisan and find the joy in food again. I am about to visit my Dad, where I will cook him some of our favorite dishes: hazelnut and tomato bake, cheese omelette, and rhubarb crumble with ice cream. If I am lucky I will buy food from the local farmers market and from the local grocers, knowing where my food comes from.
I know my small food businesses and food entrepreneurs don’t forget that food is joy. They create happy moments with food every day. You should do the same.
So you have a food product that you’ve made that people LOVE and are demanding that you take their money for it. You’re having fun in the kitchen and designing labels and suddenly you are told that if you want to sell your product you need a HACCP plan. You look online and you talk to people you know who work in the food industry and you are told, you don’t need a HACCP plan, you need a FSMA food safety plan. All these food safety acronyms: HACCP, FSMA, GMPS, SOPS, CCPs. PCs, FDA, USDA. I once challenged my undergraduate students to list as many acronyms to do with food safety as they could. My best student listed 72!
As a food start-up, where do you start?
You have so much to worry about; how can you understand what is meant by a HACCP plan or by a prerequisite program around GMPS. You want to make the best quality food product you can and of course that includes safety as well as flavor, texture, packaging etc. But…
So you’ve been asked for your HACCP or food safety plan and don’t know what that means. Sometimes you need a food safety plan/HACCP to get through your inspection. Or perhaps a wholesale customer has asked what you do for safety and someone mentioned the Food Safety Modernization Act (FSMA; pronounced Fizma) because your product doesn’t contain meat.
So what’s the difference and, more importantly, which one do you need?
Both HACCP and Food Safety Plans use scientific information to investigate what the hazards of your product are and how they can be controlled.
Both consider three types of hazard: biological, chemical and physical. Chemical hazards typically includes allergens and radiological hazards.
Both plans expect you to have foundational programs in sanitation and other stuff that come under the guidelines of Good Manufacturing Practices also known as prerequisite programs.
Both programs expect that you will monitor the steps that remove the hazards. FSMA food safety plans also expect you to list and monitor steps that reduce or control hazards. So there is one difference.
FSMA food safety plans also require you to have a recall plan, and permit you to control your hazards through sanitation controls or supply chain controls. These aren’t part of a HACCP plan.
So which plan do you need?
For Federal regulations there are three situations that you are required to have a HACCP plan:
If you make a product containing meat or poultry which is inspected by USDA;
if you make a juice; and
if you make a product containing seafood.
All other products, which come under FDA jurisdiction, require a food safety plan.
HACCP stands for Hazard Analysis and Critical Control Points and the principles surrounding HACCP have been around since 1960s. FDA expanded on these principles when they wrote FSMA regulations. So if you have a HACCP plan, it can be part of your FSMA Food Safety Plan.
Whether you follow a HACCP plan and have critical control points or if you follow an FDA food safety plan with preventive controls, the end point is the same: making your product safer for your consumer. Both HACCP plans and Food Safety plans are food safety management tools.
In a later post, I will discuss more about what goes into writing of both plans. In the meantime if If you are still reading and aware that you need to get started on your food safety plan ASAP (ooh another acronym) click here to schedule a time to speak with me. The first call is free!!!
Have you observed that there is a great injustice in the food system? That many people do not have access to nutritious food? Have you wondered what you could do to help? This inequality in the food supply was the one of the reasons I left academia and started the Food Industry Employment Program. I was frustrated because I could see that the food supply was not fulfilling the true needs of the consumer or the public. While we were being told that manufacturers supplied the consumer’s demand for high fat, high sugar and high salt food products; this carefully ignored the fact that the demand came from the ease at which these were available to manufacturers.
I saw the disconnect from the wealthy-healthy food movement. This is made up of mostly white people at my local food coop or shopping at Wholefoods. They have little, if any, conception of how food is made and how much it really cost to get food to the table.
The percentage of people with diabetes doubled in 20 years from ~4.7% deaths in 1996 to 9.5% deaths 2016 and heart disease continues to be the top cause of death in the USA.. People from low economic backgrounds suffer more from the lack of fresh fruit and vegetables and the consequences of the trauma of poverty and a poor diet. Why is that, and what can we do?
“The challenge is designed to create dedicated time and space to build more effective social justice habits, particularly those dealing with issues of race, power, privilege, and leadership. Participation in an activity like this helps us to discover how racial injustice and social injustice impact the food system, to connect with one another, to identify ways to dismantle racism and become better leaders for a more just, equitable food system.”
A couple of the initial readings really help me put the different terminology into perspective. What do the different terms like social justice, racial equity, and food sovereignty really mean? First of all, we need to recognize that for some people the current food system is working fine. They have work, they are paid well, they get enough healthy nutritious food to eat. For those of us who recognize that the food system is problematic, there are different approaches that can be taken. In this Food First backgrounder, Eric Holt-Giménez describes four different approaches to changing the food system:
The first two don’t really change the current system as much as build on it. The World Bank, the International Monetary Fund and multi-national corporations are part of this form of change. The last two are food movements. In the backgrounder, food justice is given as a progressive change, which while still working in the current food system, makes changes by economically and otherwise supporting minorities, local food producers, farm laborers and food workers. Food sovereignty is a radical restructuring and reinventing the food system. In the food sovereignty model of change, the people who make the change are the people most affected by that change.
I tend to hover between these last two. I grew up with privilege and I have worked in the food industry long enough to recognize that radical change is challenging and for it to occur there would have to be a political restructuring in many governments and in the United Nations. The focus/mission of the World Bank and International Monetary Fund would have to be totally redirected. I’m not sure how the food sovereignty movement builds the power needed to change international organizations.
In the meantime, I continue to help food entrepreneurs and small food businesses work their way through the myriad of food regulations, so that they can stay compliant and grow their businesses by producing high quality and safe food. We are changing the food system one step at a time through our commitment to values such healthy, agroecology, fair trade, and fair labor. In that way we build a sustainable and resilient food system.
If you want to something less radical, what about helping out at your local food bank or food pantry? Or perhaps look an opportunity to help at a community garden or glean foods that are not harvested. Shopping at a farm stand or local farmers market is an action to change and you get fresh, tasty food from a local farmer. Or find your Slow Food chapter.
Leave a comment below to let us know what you are doing or plan to do to make food more accessible to all.
Bacteria shouldn’t survive on dry food such as flour, flaxseed meal,chocolate and black pepper. Or so we thought. Food science has a mysterious measurement called water activity which shows how much water is present in a food that is available for microorganism growth. Moisture content lets us know the total amount of water in a food. Water activity is a key factor in food preservation; like pH. Water activity runs from 0, which is no water to 1.0 which is pure water. Food scientists have known that if water activity is less than 0.6 no microorganism growth can occur. In fact, bacteria need a water activity of 0.85 before they can grow. So why did Norway just have an outbreak which was most likely caused by a dried nut mix?
I am a very frustrated consumer and food science professional. I have been doing a hazard analysis and looking up all the ingredients I and my clients use. Pretty much every ingredient, especially if they are processed, has been involved in causing foodborne illness or been part of a recall because they might contain pathogens. This is pretty shocking as this implies we have a serious problem with food manufacturing in the US. Initially, I thought that recalls showed that the system is working, especially if no one became ill. Well it is in a way, if food is withdrawn from the market before anyone gets ill. However, managing a food supply by responding to the potential threat of Salmonella etc. AFTER they have been found in a manufacturing facility is NOT a safe food system. So now I believe that recalls show we have a broken food system.
On top of all that, the American Ambassador to Great Britain claims that American agriculture is science and technology based whereas the EU uses traditional methods which should be in a museum! That will please the Germans! Britons, so far, are unimpressed with the idea of an open trade agreement with the US especially around food. There have been quite a few rebuttals from British farmers. James Rebank had a couple of great responses on Instagram. Additionally, Sustain showed that there are more foodborne illnesses per capita in the US compared to the UK, refuting his claim that US food manufacturing is safer than British ag. Did you know that your US chicken was chlorine rinsed?
What have we done?
Why are so many people in the US getting ill from food poisoning?
How many products made by small food businesses fall through the cracks?
How many small manufacturers check to see if they have bacteria in their facility?
How many food entrepreneurs consider food safety serious issue equal to marketing?
There has to be a better more sustainable, more resilient way to produce food on a large scale. The large manufacturers must know the risks. Do small food businesses? Is local food the answer? What do you think are the next steps to improving our food system? Comment, share, and keep the conversation going.
Noncompliance equals death seems to be turning into my tagline. Am I being over the top? Sadly not. According to the CDC, about 3000 people die from foodborne illness each year. That’s not counting the ones left serious/gravely ill. Which pathogens are most dangerous? For healthy adults, most pathogens will give a few days of discomfort (vomiting, diarrhea, fever). However, the response for at risk groups (young children, elderly adults, immunocompromised and pregnant individuals) is much more severe and more likely to be fatal. There are many food pathogens. The CDC has data showing which are more likely to cause illness, hospitalization, death. This is within the known causes of foodborne illness; more than 50% of cases remain unresolved.
C. botulinum is a problem in canned and bottled food because there is little or no oxygen present. The lack of oxygen reduces the chance of spoilage organisms but if we remove oxygen and C. botulinum will thrive. These bacteria are known as obligate anaerobes as they cannot survive if oxygen is present.
There are two types of heat treatment you can use to control C. botulinum, depending on whether your food is high in acid or not. C. botulinum does not like acid, so high acid foods can be boiled for a set time to kill the bacteria. Low acid foods, especially if they also are high moisture, must be heated to temperatures well above boiling. C. botulinum produces spores when under stress conditions that would kill other bacteria, such as Listeria or Salmonella spps. Spores are like the seeds for the bacteria and when conditions improve these spores germinate and release botulinum toxin, aka botox. Yes, the botulinum toxin which causes botulism is Botox and is used to remove wrinkles and helps a friend with her migraines..
To destroy C. botulinum and prevent spores in low acid food requires a temperature above boiling (>240 oF/116 oC;guide to temperatures and food preservation). This can be reached at home in a pressure canner. To show that food has been manufactured properly, temperature must be measured with a calibrated thermometer and records must be kept.
Processed food is divided into low acid and high acid food because C. botulinum cannot survive in high acid foods. People who make canned tomatoes and other mid-acid foods measure the acid content by measuring pH and reduce the pH so that the final product has a pH below 4.6 (more about pH and food). The acid level in food is measured as pH with a calibrated pH meter and records must be kept.
Reducing the water content can also reduce C. botulinum. Food technologists measure water activity (more about water activity) which is a more accurate measurement than moisture content of whether bacteria will grow in a food. To stop bacteria from growing, water activity should be below 0.85. This can be measured with a calibrated water activity meter and records must be kept.
In summary, while C. botulinum rarely causes foodborne illness, when it does it causes death. Therefore, the food entrepreneur must have constant vigilance to ensure that the food they are making is low acid, low moisture and/or heat treated and records to match their control method..