FSSC 22000 version 5.1 Requirements

This article will be discussing FSSC 22000 version 5.1 which came out in November of 2020. There are 15 new additional requirements that you need to take note of and we will be fleshing these out and discussing them, giving examples of how you can implement this in your organization.

We will be focusing on part two of the scheme which is the requirements for organizations to be audited. The target audience who would be interested in this discussion are those who are part of an organization in the food supply chain needing to implement the schemes additional requirements or if you are an auditor or consultant needing to familiarize yourself with the additional requirements of the scheme or any organizational individual in the food supply chain who is interested in the requirements of the scheme.

The objective of these articles is firstly to become familiar with the additional requirements of the scheme and secondly to identify ways to address the additional requirements in your organization. We will be looking at quite a lot of examples and discussing them to give you a good understanding of how you can implement this in your organization.

It is an imperative prerequisite that you have knowledge and experience of FSSC 22000. You need to have a working knowledge of quality management systems and it would be very helpful to have a copy of the FSSC 22000 scheme version 5.1 with you. You can download it here.

Version 5.1 of the FSSC 22000 scheme was published in November of 2020. The scheme is organized in to six parts. Our focus will be on part two, the requirements for organizations to be audited. It defines the requirements to achieve and maintain FSSC 22000 certification. There are nine different categories of the scheme. They are:

  • 3.1) Farming of animals (Category A)
  • 3.2) Food Manufacturing (Category C)
  • 3.3) Animal Feed Production (Category D)
  • 3.4) Catering (Category E)
  • 3.5) Retail and Wholesale (Category F)
  • 3.6) Transport and Storage (Category G)
  • 3.7) Production of Food Packaging and Packaging Materials
  • 3.8) Production of Biochemicals
  • 3.9) FSSC 22000 – Quality

You need to identify into which category your organization falls. For more information on this and all the subcategories you need to look at table in section 3 of the scheme overview you will find that on page 8 onwards of the scheme. With the requirements you will see a table there and you need to identify the category and the subcategory that your organization falls under. There’s a description and a little example of the type of production taking place. If you’ve identified in which category and subcategory you fall in to or your organization falls into then on the right hand side you will find the PRP specified for that exact subcategory.

PRPs for relevant subcategory
So for instance we’ve just taken a snippet out of category one as shown in the image below. Let’s say you fall under subcategory a1 then these are the three PRPs highlighted in yellow that need to be implemented. You’ll see the third one it says FSSC 22000 additional requirements and that is the one that we will be talking about here.

The FSSC previous version had seven additional requirements and this new version 5.1 has 15 additional requirements so there’s a considerable increase in the number of additional requirements that we should adhere to.

The first additional requirement is the management of services and purchased materials. There is specific care about purchase material, firstly about the laboratories you use. Any laboratories that we use for validating or verifying food safety have to be competent, and competent means that they have to be capable to produce precise and repeatable test results using validated test methods. What this essentially means is that your lab has to be accredited or your lab has to be a part of a proficiency scheme. You can’t just do microbiology on an on-site lab without that lab demonstrating that those results are repeatable so you can’t merely just have a corner in your facility where you do testing. Your laboratory results have to be compared to an accredited laboratory that uses accredited methods for that test.

One side is validation but when we look at the verification of food safety that’s looking at final product testing, your hand swabs, your equipment swabs, and essentially any micro test that you do. You’re only doing it to validate or verify so needs to be done by competent lab. If you have an on-site lab the ideal thing would be that lab being accredited however you can have an unaccredited lab on site but then you need to make sure that your lab is doing either inter-lab testing with other accredited labs or on a proficiency scheme so that the results are proven or shown to be valid. They must be shown to be repeatable.

So for categories C, D, I, G and K there needs to be a documented procedure to procure in the event of an emergency, to ensure the final product conforms to specification. You have to control your suppliers so that when you run out of something you have approved suppliers ready to supply you. You can’t just randomly approve or randomly procure something from someone without them being approved on your approved suppliers list. We can’t just go to someone else and quickly get something, for instance tomato sauce. If you use this particular tomato sauce in your product and you’ve been buying for the last 15 years from the same client and everything’s been perfect. Then all of a sudden the factory burns down and they can’t supply you because they run out of stock, you need to have a plan in place to make sure that the supplier you’re going to buy your new tomato sauce to make your product, is approved.

For each and every raw material that you’re going to use you need at least two suppliers on that approved buyer list so that you’ve always got a backup supplier in place for all your raw materials. When procuring animal, fish and seafood there’s a need for a policy to control prohibited substances. We know for a fact that in the beef industry cows can often get sick with bovine tuberculosis and brucellosis. When they are sick the get injected with vitamin residues or veterinary medicines that create residues so you have to make sure that you’ve got a program in place to ensure that sick cows are not entering the supply chain.

The same goes with fish. There’s been serious studies done globally that different levels of fish are actually picking up pesticide residues and heavy metals from the different water sources so you must make sure that you’ve got a program in place to mitigate the potential risks. Luckily Europe and North America have very strong standards when it comes to heavy metals, pesticide residue levels and veterinary medicines. You just have to make sure that you’ve got documents in place to specifically manage those hazards.

There might be certain countries that don’t have the correct pesticide residue levels. The FSSC requires that if you want to meet these additional requirements you need to make sure you have a process in place for any hazards. That will involve you needing to research which hazards are associated with the products you are making and what sort of best practices you should implement.

Probably one of the best places to look at that would be codex elementaries. Lastly there needs to be a review process for product specifications to ensure compliance with food safety, legal and customer requirements. That basically means that if we have a specification in place but it’s been like that for years we can’t just leave it there and let it sit. We have to actually go back to it and review it exactly, so from a product specification perspective let’s think of our tomato sauce example again. You have a specification in place, you procure that specification and you’ve used it for the last 10 years and it’s fine but you need to make sure that at a predefined interval, probably annually but it depends on the nature of the product and the risk of the product, that you revise it and make sure that it’s still current.

The whole point of this is really making sure that the ingredients that are coming in, especially when it’s a compound ingredient like tomato sauce, have not changed. This is not necessarily just with ingredients but also maybe the laws have changed, maybe the heavy metal limits have changed and now all of a sudden your specification that used to be at a certain level is now illegal. So you need to make sure that it becomes current.

So it does form part of the HACCP review process if you’re doing that properly however the FSSC additional requirements say you need emphasis on making sure that you review your specs at a predefined interval. So whether it is every year or every three years, it doesn’t matter, you need to determine that based on your risk but you need to justify your risk.

Share this article