High-risk and high-care facilities

The requirements

High-risk and high-care facilities

The purpose of high-risk and high-care facilities is to protect the product from pathogenic contamination. This means that the controls applied must be based on risk.

Risk assessment

Where you apply the requirements for high-risk and high-care exactly as described by the Standard, you don’t need a documented risk assessment. However, where you deviate from what’s expected – then your auditor will challenge you and ask you for your risk assessment that justifies why the controls you have in place are sufficient.

This risk assessment must be robust. This means you have to prove why your controls are acceptable and why those described in the Standard aren’t necessary. And make sure you do this through objective evidence such as data, as your subjective information isn’t sufficient.

If you need to carry out a risk assessment, you’ll need to identify what your target microbial hazards are (specific pathogens) and your evidence and data will need to support these specific hazards.

Segregation

There are different rules for segregation of high risk and high care:

• High risk must have physical segregation using floor to ceiling barriers (such as walls).
• High care ideally should have physical segregation, but where this isn’t possible additional controls can be applied instead (defined by risk assessment as we’ve talked about above).

Transfer points

Anything entering the segregated high-risk or high-care area must be decontaminated prior to entry, to ensure that pathogenic contamination isn’t transferred into the area.

Decontamination can be achieved using either cleaning techniques or treatments of:

• Equipment and tools.
• People.
• Materials.

Materials

Materials can be transferred using decontamination techniques such as:

• Passing disinfected materials through a hole in the wall.
• Pulling inner packed materials (packaging) into the area, leaving the outer packaging behind.
• Sanitising tunnels.
• Travelling ovens or double door ovens.
• Chlorine baths.

The decontamination process must happen during the movement from low-risk to the high-risk or high-care area. Or at the very least, immediately before entry to high-risk or high-care. Where materials are treated in low-risk and then pass through to high-care or high-risk, you need an extremely robust justification to prove why this is acceptable.

Materials entering high-risk facilities

All materials must be treated so that they achieve at least a 6 log reduction of Listeria monocytogenes.

Materials entering high-care facilities

All materials must be treated so that they achieve at least a 2 log reduction in Listeria monocytogenes.

It’s acceptable for the treatment of the materials to occur at the supplier, but if they do then you’ll need to verify this routinely. And of course, the material must be cleaned again in its packed state – prior to entering the area on site.

Fabrication

The design of fabrication and equipment in high-risk and high-care areas, must not pose a risk of contamination. Check that doors don’t pose a risk – roller lifting doors may represent a risk when raised, because they’ve been in contact with the floor.

Drains

Drains must flow away from high-risk and high-care. There must be a drain schematic which shows the direction of flow and the location of any equipment fitted to prevent the back-up of waste water.

Drains must be designed to ensure constant flow, by fitting equipment such as anti-syphon valves.

If drain traps fail or drains back up, a procedure must be in place which details what action must be taken, including clean-up procedures and verification prior to start up.

Air

The Standard states that only high-risk facilities must be supplied with sufficient changes of filtered air and be under positive air pressure.

If you have a high-risk area, you’ll need a risk assessment which defines what:

• The filter specification needs to be.
• The frequency of air changes.
• The specification required to maintain positive air pressure.

To ensure that the system is effective you’ll also need to define:

• The frequency of filter changes and air socks (where used).
• The method and frequency of cleaning of the air system.
• The method and frequency of air sampling to verify the system is working effectively.

Positive air pressure means that air should not flow from other areas into high-risk. This can be measured, but a good way of doing a quick and simple check – is to hold a piece of paper up in the area. If the air flows from high-risk to low-risk as it should, then the paper should be blown toward low-risk.

High-risk air socks must be identifiable and stored separately from socks used in other areas.

People movement

Decontamination of people require personal hygiene and protective clothing controls. Access to high-risk and high-care must only be through the changing facilities.

Changing facilities

Changing facility procedures must include:

• Visually distinctive protective clothing from other areas.
• The following instructions for changing in this order:
  • Put on hair covering.
  • Remove shoes.
  • Step over barrier (see below).
  • Put on dedicated footwear.
  • Wash hands.
  • Put on coat or overalls.
  • Wash and sanitise hands.

There must be clear instructions for changing out of protective clothing to ensure that the overall is removed before handling shoes or hair coverings.

Workwear

Protective clothing must be provided in sufficient quantities so that it can be changed at least daily or when necessary, based on risk assessment. Hairnets must be changed daily or whenever they’re removed.

Footwear

Footwear must be provided by site and must not be worn outside. Shoe covers aren’t acceptable.

Footwear must be captive to the area – this means that you can’t wear it in any other area. The footwear must be put on, after stepping over a barrier system. The barrier system is a bench which divides the changing area, and separates the low risk side from the high-care/risk side.

Where this can’t be achieved and is thoroughly justified through risk assessment, footwear can be cleaned instead, using a bootwash for example. The risk assessment and procedure must identify all the controls that are needed, including:

• How the barrier will be maintained.
• Where the bootwash is located, so not to cause product contamination.
• Validation of the cleaning system.
• How the system should be verified, including chemical changes and concentrations.
• How the system should be kept clean.
• What environmental monitoring is needed.

Handwashing

Sinks must be placed so that hands can be washed:

• Before entering high-risk.
• At least at the entrance to high-care.

Laundry

Laundering of protective clothing for high-risk and high-care areas must be carried out by:

• An approved contractor.
• In-house laundry.

The laundry controls must be in place, validated and verified. This must include internal auditing of in-house laundries or auditing of contracted laundries – at a risk-based frequency.

Cleaning procedures

Cleaning procedures in high-risk and high-care must include:

• Who is responsible for cleaning.
• The equipment or area to be cleaned.
• Frequency of cleaning.
• Method of cleaning, including dismantling equipment for cleaning purposed where required.
• Chemicals and concentrations.
• Materials and equipment to be used.
• Cleaning records.
• Verification methods and responsibility for verification.

The frequency of the cleaning must be determined through risk assessment. Methods of cleaning must be validated to ensure that appropriate standards of cleaning are achieved.

The procedures need to be reviewed and updated when changes occur which affect the methods.

Cleaning verification

Microbiological limits for acceptable and unacceptable cleaning must be defined. The limits must be validated and based on the potential hazards relevant to the product or area.

There must be corrective action procedures which details what to do when the acceptable limits aren’t met following cleaning.

Cleaning equipment

Equipment used for cleaning in high-risk and high-care must be:

• Visually distinctive.
• Dedicated for use in that area.
• Suitable and clean.
• Must not create aerosols or move debris around.

Hand-back

There must be hand-back procedures and records in place, following cleaning and maintenance, prior to production start-up.

Equipment and tools

Equipment and tools should ideally be dedicated to the high-risk and high-care area, so that they don’t need to be moved. They must be identifiable such as colour-coded.

This includes tools and equipment for:

• Maintenance.
• Pest control.
• Cleaning.

Where this isn’t possible, it must be cleaned and disinfected prior to re-entry. There must be a designated transfer point to allow for cleaning immediately prior to transfer.

Mobile or portable handheld equipment must be clearly identifiable, so that they can be segregated to the area.

Waste

A risk assessment must determine how waste and waste containers must be handled and the controls that are needed.

The route of disposal of waste must be controlled so that it doesn’t contaminate product.

The containers must be dedicated to the area.