Defining risk-based zones

Contents

• The standards.
• The requirements.
• BRCGS Food Safety Issue 9.
• What risk-based zones are.
• How to determine risk-based zones.
• Risk-based zone definitions.

The standards

This article is written to meet the following sections of the standards:

BRCGS Food Safety Issue 9	4.3.1 Production risk zones. 4.3.2 Site map. 8.1.1 Production risk zones on the site map.
BRCGS Packaging Issue 6	Not applicable.
BRCGS Agents & Brokers Issue 3	Not applicable.
BRCGS Storage & Distribution Issue 4	4.3.1 Site map. 4.3.2 XD Layout and flow. 9.1.1 Open food site map.
FSSC22000 Version 5.1	ISO 22000 4.3 Determining the scope of the food safety management system.
IFS Food Version 7	4.8.3 Sensitive areas.
SQF Edition 9	11.7.1 High-risk processes.
FSMA Preventive controls for human food (Final 2015)	No specific reference.

The requirements

Zones must be defined, into the following types:

• High-risk.
• High care.
• Ambient high care.
• Low risk.
• Enclosed product.
• Non-product.
• External.

An assessment must be completed to define risk-based zones, to mitigate the risk of cross-contamination of product.

What risk-based zones are

A ‘zone’ is a defined area within a site. A ‘risk-based zone’ protects the product from risks from outside of that zone.

‘Risk-based zones’ is a collective term used to describe the following types of zones:

• High-risk.
• High care.
• Ambient high care.
• Low risk.
• Enclosed product.
• Non-product.
• External.

‘Risk’ is a collective term, that’s used to describe something that can cause a problem. Risks include hazards (for product safety), violations (for product legality), threats (for product defence), and defects (for product quality).

How to determine risk-based zones

In previous issues of BRCGS Food Safety, a decision tree has been provided. However, this was really confusing (you may remember we published an article about how it didn’t work).

For Issue 9 they’re removed this decision tree and have replaced it with an explanation, which in our view doesn’t help either.

This means that you now need to determine the risk of each of the zones, and provide justification of your reasoning.

Below are some definitions to help you. We’ve also come up with our own decision tree, which we teach in our mini training – defining risk-based zones.

Risk-based zone definitions

BRCGS definition of high-risk and high-care areas

The BRCGS state that the difference between these areas is:

• The aim of a high-risk area is to prevent the risk of pathogenic contamination.
• The aim of a high-care area is to minimise the risk of pathogenic contamination.

Definition of a high-risk product

The UK Food Standards Agency states:

“Products may be considered high-risk if they contain, for example, contaminants such as mycotoxins, pesticides, salmonella.”

Therefore, a high-risk product is one which is known to contain a contaminant which has the potential to cause harm.

However, the BRCGS definition of a high-risk product is:

“A chilled or frozen ready-to-eat/ready-to-heat product or food where there is a high-risk of growth of pathogenic micro-organisms.” – BRCGS Food Safety

You can see here, BRCGS are talking about the product after treatment. Whereas the FSA are referring to the product before treatment. Very confusing!

Definition of a high-care product

The BRCGS state that a high-care product is:

“A product that requires chilling or freezing during storage, is vulnerable to the growth of pathogens, has received a process to reduce microbiological contamination to safe levels (typically 1-2 log reduction) and is ready to eat or heat.” – BRCGS Food Safety

So, again this supports the theory that what happens to the product before it goes into the area – is what defines whether it’s high-risk or high-care. A greater log reduction (6 log) would be high-risk and a lower log reduction is high-care. Why, this makes a difference to how much contamination the product can withstand when the product is actually in the area – we’re not sure.

Ambient high-care

To confuse matters even further we also have the term ‘ambient high-care’. This is basically a high-care product that doesn’t have to be stored in a chilled or frozen environment.

This was added into the BRCGS Standard in Issue 7, as a response to pathogenic contamination of ambient products, such as chocolate. However, because these products are ambient stored, they didn’t fit into the existing high-risk and high-care definitions. So, a new category of ambient high-care was introduced.