15. Risk-based facilities
High-care, high-risk and ambient high-care controls
We look at why this topic is so confusing and try to make sense of the definitions
High-risk, high-care and ambient high-care controls
This article explains how to detail your high-risk, high-care and ambient high-care controls in a procedure.
The standards
High-risk, high-care and ambient high-care controls
This article is written to meet the following standards:
| BRCGS Food Safety Issue 9 | Section 8 – Production risk zones – high risk, high care and ambient high care |
| BRCGS Packaging Issue 6 | Not applicable |
| BRCGS Agents & Brokers Issue 3 | Not applicable |
| BRCGS Storage & Distribution Issue 4 | Not applicable |
| FSSC22000 Version 5.1 | No specific clauses |
| IFS Food Version 7 | 4.8.3 Product safety areas |
| SQF Edition 9 | 11.7.1 High-risk processes |
| Additional standards | TESCO |
The requirements
High-risk, high-care and ambient high-care procedure
There must be a procedure in place which details the controls required for risk-based zones. The controls, must be determined based on risk assessment.
To find out more about how to determine risk-based zones, take a read of our article; Defining risk-based zones.
The risk assessment must determine which areas on site are:
- High risk.
- High care.
- Ambient high care.
- Low risk.
- Enclosed product.
- Non product.
- External.
You may also have zones which control allergen cross contamination, however the standards do not refer to these specifically. The controls for allergen zones, only tend to be detailed in customer standards.
The procedure must detail the controls which minimise the risk of cross contamination, including aspects such as:
- Transfer points and segregation of materials and product.
- People flow and PPE.
- Fabrication.
- Air.
- Equipment and tools.
- Waste.
Details of the specific controls required for high-risk, high-care and ambient high-care zones will be covered in the following articles on this topic.
BRCGS Food Safety Issue 9
There are no specific requirements that were amended or added in the BRCGS Food Safety Issue 9 standard with regard to the high-risk, high-care and ambient high-care procedure. The following articles in this topic cover the changes to the specific requirements for ambient high care zones, and high-risk and high-care zones.
Defining risk-based zones
This eLearning course will teach you everything you need to know about defining risk-based zones. It’s designed for food safety experts who are part of the product safety team (or HACCP team).
It includes our easy to follow decision tree for determining what risk-based zones you have on site. The course guides you through the process so that you can document and justify your reasoning.
Morning Kassy
Can you please comment on the removal of the word ‘vulnerable’ from Appendix 2 on BRCGS v9. High risk ingredients vulnerable to the presence of pathogens to have a 6 log kill stated in BRCGS v8. Does this now mean that sugar, salt, vinegars, spirits, pasteurised egg etc have to have the 6 log kill step before entry into High Risk, as this is how it now reads?
Hi Deborah, I think I’m being blind, but I can’t find this text in Issue 8 so that I can compare it to Issue 9. Can you please tell me what page and paragraph it is that you’re referring to?
Kassy
I think it also adds complication as BRC specifies “Heat Treatment” to have 6 log reduction, however there are other technologies that can achieve this reduction with validation in place such as HPP.
How would this work during an audit if you use ingredients that have been treated with validated 6 log reduction HPP step in High Risk production?
Thank you
Hi Reni
In theory, if you can prove it through a 6-log validation it shouldn’t be a problem. However, an auditor would be sceptical, so your validation would have to be really robust.
Kassy
The Full cook statement does have a footnote – “Cook’ is a thermal process which is designed to achieve typically a 6 log reduction in Listeria monocytogenes equivalent to 70°C for 2 minutes. Alternative cooking processes may be accepted or required where these meet recognised national guidelines and are validated by scientific data. Note that other processes achieving a 6
log reduction (e.g. irradiation, high-pressure processes) should be considered in the same way as conventional ‘cook’ processes.”
Just to add a few thoughts to this:
Regarding milk pasteurisation, this is high-care rather than high-risk. The answer to question 5 was incorrect, which is why the wrong conclusion was drawn. Milk has not been heat-treated to 70°C for 2 minutes. It has been heat-treated, but for less than this (typically 72.6°C for 15 seconds) which is why this would come up as high-care. The answer to question 5 would be no.
There are some pretty significant differences between high-risk, high-care and ambient high-care.
Ambient high-care is only 2 clauses (8.1.1 and 8.1.4), the rest of section 8 is not applicable.
High-risk requires practices to minimise contamination during transfer (e.g. disinfection of materials on entry) where as high-care doesn’t. In fact high-care doesn’t actually need physical barriers at all and would be perfectly acceptable to have other risk based controls such as time or space segregation, as well as the other things you’ve mentioned.
That said, I think it would be beneficial for the requirements of risk zoning to be made simpler and clearer and whilst I don’t think it should be just high-risk vs low-risk, I think there could be some benefit for the site to determine which risk based controls they need from section 8, depending on the product. Perhaps something like how BRCGS Packaging Materials (issue 6) now works with the risk-based deviations.
The risk issue also comes up in the BRC Agents & Brokers and Storage & Distribution Standards. This time it is what do you define as Low Risk? If your product is low risk you can get away without GFSI or site audits which is a big issue for some. I can’t find any criteria to help the definition, so it is a case of auditor interpretation against mine.
A very interesting and useful article, Kassy, and it is very helpful to compare BRCGS with FSSC 22000 v5, for example. Your key question is “why make it so complicated and how does that help?” and I think it really is a good question to ask. With the definitions varying from one source to another (e.g. BRCGS from FSA), I can see that it really is time for a rethink. For example, I am also not sure how we class cut up fruit which is ready to eat, and salads?
Hi Susan
OK thanks – I’ll do that. I’ve not looked at FSSC – I had assumed (and you know what that does!) that FSSC wouldn’t give us much info, becuase it’s such an open and flexible standard.
On your question about cut up fruit and salads – they would typically be high care.
Kassy
There is a difference between high risk/care AREAS and the foods themselves.
In production zone standards the word ‘risk’ refers to that presented BY the production AREA to the food, not the food itself.
A RTE/RTRH food that is fully cooked (min 70/2) but not processed in-pack needs to be handled post-process under particularly rigorous hygiene conditions to protect it from environmental contamination, ie HRA.
RTE/RTRH food with a raw component has not been treated to 70/2 throughout so is inherently at greater risk of carrying micro contamination. (Note that CFA guidelines require raw components such as produce to have undergone a decontamination process but this is not equiv to 6-log reduction of target organisms. More like 1-2 logs). High hygiene standards are of course required for handling open product, but it is recognised that the presence in the food of non-70/2 component(s) means that there is less benefit in applying full HRA conditions, hence HCA is appropriate.
A non-RTE/RTRH food that is completely raw (all components <70/2) is inherently greater micro risk to a GMP standard production environment than vice versa.
For something like pasteurised milk risk assessment of the area hygiene and duration of exposure to the environment post-pasteurisation would be appropriate to determine the hygiene area standard required.
Hi Karin,
Thanks for this – unfortunately your view of RTE/RTRH doesn’t align with high-risk and high-care. A sandwich is RTE but generally produced in a high-care area….
What is the benefit in having different standards for high-risk and high-care areas, producing RTE products – in your view?
Kassy