8. High-Risk, High-Care and Ambient High-Care Production Risk Zones
8.1. Pest Management
FUNDAMENTAL
1
Clause 8.1.1
The map of the site (see clause 4.3.1) shall include areas (zones) where the product is at different levels of risk from contamination. The map shall show:
Outcome Docs Actions Notes
Yes No N/A
Does the map of the site (see clause 4.3.1):
Is this zoning taken into account when determining the prerequisite programmes for the particular areas of the site?
Clause 8.1.2
Where high-risk areas are part of the manufacturing site, there shall be physical segregation between these areas and other parts of the site. Segregation shall take into account the flow of product, the nature of the materials (including packaging), the equipment, the personnel, the disposal of waste, the flow of air, the air quality, and the provision of utilities (including drains). The location of transfer points shall not compromise the segregation between high-risk areas and other areas of the factory. Practices shall be in place to minimise the risk of product contamination (e.g. the disinfection of materials on entry).
Outcome Docs Actions Notes
Yes No N/A
Where high-risk areas are part of the manufacturing site, is there a physical segregation between these areas and other parts of the site?
Does segregation take into account the:
The location of transfer points does NOT compromise the segregation between high-risk areas and other areas of the factory.
Clause 8.1.3
Where high-care areas are part of the manufacturing site, there should be physical segregation between these areas and other parts of the site. Segregation shall take into account the flow of product, the nature of materials (including packaging), the equipment, the personnel, the disposal of waste, the flow of air, the air quality, and the provision of utilities (including drains). Where physical barriers are not in place, the site shall have undertaken a documented risk assessment of the potential for cross-contamination, and effective, validated processes shall be in place to protect products from contamination.
Outcome Docs Actions Notes
Yes No N/A
Where high-care areas are part of the manufacturing site, is there a physical segregation between these areas and other parts of the site?
Does segregation take into account the:
Where physical barriers are not in place:
Clause 8.1.4
Where ambient high-care areas are required, a documented risk assessment shall be completed to determine the risk of cross-contamination with pathogens. The risk assessment shall take into account the potential sources of microbiological contamination and include:
Outcome Docs Actions Notes
Yes No N/A
Where ambient high-care areas are required, has a documented risk assessment been completed to determine the risk of cross-contamination with pathogens?
Does the risk assessment take into account the potential sources of microbiological contamination?
Does the risk assessment include:
Are effective processes in place to protect the final product from microbiological contamination?
Do these processes include segregation, management of process flow or other controls?
8.2. Pet Food
FUNDAMENTAL
1
Clause 8.2.1
Where sites include high-risk or high-care facilities, there shall be a map of the drains for these areas which shows the direction of flow and the location of any equipment fitted to prevent the back-up of waste water. The flow from drains shall not present a risk of contamination to the high-risk/care area.
Outcome Docs Actions Notes
Yes No N/A
Where sites include high-risk or high-care facilities, is there a map of the drains for these areas, which shows the:
The flow from drains does NOT present a risk of contamination to the high-risk/care area.
Clause 8.2.2
High-risk areas shall be supplied with sufficient changes of filtered air. The filter specification used and frequency of air changes shall be documented, based on a risk assessment that takes into account the source of the air and the requirement to maintain a positive air pressure relative to the surrounding areas.
Outcome Docs Actions Notes
Yes No N/A
Are high-risk areas supplied with sufficient changes of filtered air?
Is the filter specification used documented, based on a risk assessment that takes into account the:
Is frequency of air changes documented, based on a risk assessment that takes into account the:
8.3. Prerequisite Programmes
FUNDAMENTAL
1
Clause 8.3.1
Maintenance activities undertaken in high-risk and high-care areas shall respect the segregation requirements of the area. Wherever possible, tools and equipment shall be dedicated for use in that area and retained in the same.
Outcome Docs Actions Notes
Yes No N/A
Do maintenance activities undertaken in high-risk areas respect the segregation requirements of the area?
Do maintenance activities undertaken in high-care areas respect the segregation requirements of the area?
Wherever possible, are tools dedicated for use in that area and retained in the same area?
Wherever possible, is equipment dedicated for use in that area and retained in the same area?
Clause 8.3.2
Where equipment is removed from the high-risk or high-care area, the site shall have a procedure to ensure the cleanliness and removal of contamination hazards before being accepted back into the area.
Outcome Docs Actions Notes
Yes No N/A
Where equipment is removed from the high-risk area, does the site have a procedure:
Where equipment is removed from the high-care area, does the site have a procedure:
Are records of acceptance back into the area maintained?
Clause 8.3.3
Where portable equipment (e.g. handheld devices) is used in high-risk or high-care areas, these items shall either be:
Outcome Docs Actions Notes
Yes No N/A
Where portable equipment is used in high-risk areas:
Where portable equipment is used in high-care areas:
8.4. Procedures shall be in place to ensure that the management of dispatch and of the vehicles and containers used for transporting products from the site do not present a risk to the safety, security or quality of the products.
FUNDAMENTAL
1
Clause 8.4.1
Where an operation includes a high-risk or high-care area, personnel shall enter via a specially designated changing facility at the entrance to the area. The changing facilities shall incorporate the following:
Outcome Docs Actions Notes
Yes No N/A
Where an operation includes a high-risk or high-care area, do personnel enter via a specially designated changing facility at the entrance to the area?
Do the changing facilities incorporate:
Are the hand-washing and disinfection facilities:
Do the changing facilities incorporate dedicated site footwear to prevent the introduction of pathogens into the area?
Is control before entering the area by segregation and a controlled change of footwear OR by the use of controlled and managed boot-wash facilities where these demonstrably provide an effective control of footwear to prevent the introduction of pathogens into the area?
Is a programme of environmental monitoring used to assess the effectiveness of footwear controls?
8.5. Process Control
FUNDAMENTAL
1
Clause 8.5.1
Environmental cleaning procedures in high-care/high-risk areas shall, at a minimum, include:
Outcome Docs Actions Notes
Yes No N/A
Do environmental cleaning procedures in high-care/high-risk areas include:
Which other points should be included in these environmental cleaning procedures?
Are these additional points included?
Is the frequency of cleaning based on risk?
Are the methods of cleaning based on risk?
Are the procedures implemented to ensure that appropriate standards of cleaning are achieved?
Clause 8.5.2
Microbiological limits for acceptable and unacceptable cleaning performance shall be defined for high-risk/high-care production risk zones.
Outcome Docs Actions Notes
Yes No N/A
Are microbiological limits for acceptable cleaning performance defined for high-risk/high-care production risk zones?
Are microbiological limits for unacceptable cleaning performance defined for high-risk/high-care production risk zones?
Are these limits based on the potential hazards to the product or processing area?
Are acceptable levels of cleaning defined by visual appearance, ATP bioluminescence techniques, microbiological testing, allergen testing or chemical testing as appropriate?
Is the corrective action to be taken when monitoring results are outside of the acceptable limits defined?
Where cleaning procedures are part of a defined prerequisite plan to control the risk of a specific hazard, are the:
Do records include the risk from cleaning chemical residues on food contact surfaces?
Clause 8.5.3
Equipment used for cleaning in high-care and high-risk areas shall be visually distinctive and dedicated for use in that area.
Outcome Docs Actions Notes
Yes No N/A
Is equipment used for cleaning in:
8.6. Product Authenticity, Claims and Chain of Custody
FUNDAMENTAL
1
Clause 8.6.1
Waste disposal systems shall ensure that the risk of contamination of products is minimised through the control of potential cross-contamination.
Outcome Docs Actions Notes
Yes No N/A
Do waste disposal systems ensure that the risk of contamination of products is minimised through the control of potential cross-contamination?
Does risk assessment consider the:
8.7. Product Control
FUNDAMENTAL
1
Clause 8.7.1
Laundering of protective clothing for high-risk and high-care areas shall be by an approved contracted or in-house laundry using defined criteria to validate the effectiveness of the laundering process. The laundry must operate procedures which ensure:
Outcome Docs Actions Notes
Yes No N/A
Does an approved contracted or in-house laundry do the laundering of protective clothing using defined criteria to validate the effectiveness of the laundering process, of:
Does the laundry operate procedures which ensure:
Clause 8.7.2
Where protective clothing for high-care or high-risk areas is cleaned by a contracted or in-house laundry, the laundry shall be audited either directly or by a third party. The frequency of these audits shall be based on risk.
Outcome Docs Actions Notes
Yes No N/A
Where protective clothing for high-care or high-risk areas is cleaned by a contracted or in-house laundry, is the laundry audited either directly or by a third party?
Is the frequency of these audits based on risk?
Clause 8.7.3
Protective clothing for use in high-risk and high-care areas shall be changed at an appropriate frequency based on risk, and at a minimum daily.
Outcome Docs Actions Notes
Yes No N/A
Is protective clothing for use in high-risk areas changed:
Is protective clothing for use in high-care areas changed: