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BRC Global Standard for Food Safety :8High-risk, high-care and ambient high-care production risk zones : Auditor Checklist and Site Self-Assessment Tool

The BRC Global Standard for Food Safety :8High-risk, high-care and ambient high-care production risk zones : Auditor Checklist and Site Self-Assessment Tool focuses on the site. This inspection tool offers a complete list to ensure that the site follow the relevant requirements from 1-7 of the Standard that must be fulfilled in addition to the requirements in this section. This auditor checklist also plays a vital role in checking if the site demonstrates that production facilities and controls are suitable to prevent pathogen contamintion of products.
MaintainX
04/26/2021

BRC Global Standard for Food Safety :8High-risk, high-care and ambient high-care production risk zones : Auditor Checklist and Site Self-Assessment Tool

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The BRC Global Standard for Food Safety :8High-risk, high-care and ambient high-care production risk zones : Auditor Checklist and Site Self-Assessment Tool focuses on the site. This inspection tool offers a complete list to ensure that the site follow the relevant requirements from 1-7 of the Standard that must be fulfilled in addition to the requirements in this section. This auditor checklist also plays a vital role in checking if the site demonstrates that production facilities and controls are suitable to prevent pathogen contamintion of products.
  • Where a site produces products that require handling in high-risk, high-care and/or ambient high-care production facilities (see Appendix 2 for the definition of products that

  • require these facilities), all the relevant requirements from sections 1–7 of the Standard must be fulfilled in addition to the requirements in this section.

  • 8.1 Layout, product flow and segregation in high-risk, high-care and ambient high-care zones

  • The site shall be able to demonstrate that production facilities and controls are suitable to prevent pathogen contamination of products.

  • 8.1.1The 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

  • high-risk areas

    • Pass
    • Flag
    • Fail
  • high-care areas

    • Pass
    • Flag
    • Fail
  • ambient high-care areas

    • Pass
    • Flag
    • Fail
  • low-risk areas

    • Pass
    • Flag
    • Fail
  • enclosed product areas

    • Pass
    • Flag
    • Fail
  • non-product areas.

    • Pass
    • Flag
    • Fail
  • See Appendix 2 for guidelines on defining the production risk zones.

  • This zoning shall be taken into account when determining the prerequisite programmes for the particular areas of the site

  • 8.1.1

  • 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 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).

    • Pass
    • Flag
    • Fail
  • 8.1.2

  • Where high-care areas are part of the manufacturing site, there should be physical segregation between these areas and otherparts of the site. Segregation shall take into account the flow of product, the nature of materials (including packaging)

  • 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.

    • Pass
    • Flag
    • Fail
  • 8.1.3

  • 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 contaminati

  • the raw materials and products

    • Pass
    • Flag
    • Fail
  • the flow of raw materials, packaging, products, equipment, personnel and waste

    • Pass
    • Flag
    • Fail
  • air flow and quality

    • Pass
    • Flag
    • Fail
  • the provision and location of utilities (including drains).

    • Pass
    • Flag
    • Fail
  • Effective processes shall be in place to protect the final product from microbiological contamination. These processes may include segregation, management of process flow or other controls

  • 8.1.4

  • 8.2 Building fabric in high-risk and high-care zones

  • 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 no

    • Pass
    • Flag
    • Fail
  • 8.2.1

  • 8.2.2 High-risk areas shall be supplied with sufficient changes of filtered air. The filter specification usedand 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

    • Pass
    • Flag
    • Fail
  • 8.2.2

  • 8.3 Maintenance in high-risk and high-care zones

  • 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

    • Pass
    • Flag
    • Fail
  • 8.3.1

  • 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.

    • Pass
    • Flag
    • Fail
  • Records of acceptance back into the area shall be maintained.

  • 8.3.2

  • 8.3.3 Where portable equipment (e.g. handheld devices) is used in high-risk or high-care areas, these items shall either be:

  • visually distinctive and dedicated for use in that area

    • Pass
    • Flag
    • Fail
  • have specific procedures (e.g.a full clean) to ensure that their use does not result in contamination.

    • Pass
    • Flag
    • Fail
  • 8.3.3

  • 8.4 Staff facilities for high-risk and high-care zones

  • 8.4.1 Where an operation includes a high-risk or high-care area, personnel shall enter via aspecially designated changing facility at the entrance to the area. The changing facilities shall incorporate the following:

  • 8.4.1 Where an operation includes a high-risk or high-care area, personnel shall enter via aspecially designated changing facility at the entrance to the area. The changing facilities shall incorporate the following:

    • Pass
    • Flag
    • Fail
  • protective clothing that is visually distinct from that worn in other areas and which shall not be worn outside the are

    • Pass
    • Flag
    • Fail
  • hand-washing routine during the changing procedure to prevent contamination of the clean clothing (i.e. hand-washing after hair covering and footwear have been put on, but before handling clean protective clothing)

    • Pass
    • Flag
    • Fail
  • provision and use of hand-washing and disinfection facilities. At a minimum these shall be:

  • prior to entry for high-risk areas

    • Pass
    • Flag
    • Fail
  • on entry for high-care areas

    • Pass
    • Flag
    • Fail
  • dedicated site footwear that is provided by the site and which shall not be worn outside the factory

    • Pass
    • Flag
    • Fail
  • an effective control of footwear to prevent the introduction of pathogens into the area. Control may be by segregation and a controlled change of footwear before entering the area

  • (such as a barrier or bench system) 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.

    • Pass
    • Flag
    • Fail
  • A programme of environmental monitoring shall be used to assess theeffectiveness of footwear controls.

    • Pass
    • Flag
    • Fail
  • 8.4.1

  • 8.5 Housekeeping and hygiene in high-risk and high-care zones

  • 8.5.1 Environmental cleaning procedures in high-care/high-risk areas shall, ata minimum, include:

  • responsibility for cleaning

    • Pass
    • Flag
    • Fail
  • item/area to be cleaned

    • Pass
    • Flag
    • Fail
  • frequency of cleanin

    • Pass
    • Flag
    • Fail
  • method of cleaning, including dismantling equipment for cleaning purposes where required

    • Pass
    • Flag
    • Fail
  • cleaning chemicals and concentrations

    • Pass
    • Flag
    • Fail
  • cleaning materials to be used

    • Pass
    • Flag
    • Fail
  • cleaning records and responsibility for verification.

    • Pass
    • Flag
    • Fail
  • he frequency and methods of cleaning shall be based on risk, and the procedures shall be implemented to ensure that appropriate standards of cleaning are achieved.

  • 8.5.1

  • 8.5.2 Microbiological limits for acceptable and unacceptable cleaning performance shall be defined for high-risk/high-care production risk zones.

  • These limits shall be based on the potential hazards relevant to the product or processing area. Therefore, acceptable levels of cleaning may be defined by visual appearance, ATP bioluminescence techniques (see glossary), microbiological testing, allergen

  • The site shall define the corrective action to be taken when monitored results are outside of the acceptable limits.

    • Pass
    • Flag
    • Fail
  • Where cleaning procedures are part of a defined prerequisite plan to control the risk of a specific hazard, the cleaning and disinfection procedures and frequencies shall be validated and records maintained.

  • This shall include the risk from cleaning chemical residues on food contact surfaces.

    • Pass
    • Flag
    • Fail
  • 8.5.2

  • 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

    • Pass
    • Flag
    • Fail
  • 8.5.3

  • 8.6 Waste/waste disposal in high-risk, high-care zones

  • 8.6.1 Waste disposal systems shall ensure that the risk of contamination of products is minimised through the control of potential cross-contamination.

    • Pass
    • Flag
    • Fail
  • Risk assessment shall consider the movement and flow of waste and waste containers. For example, waste bins should be dedicated to either high-risk or high-care areas and not be moved between different production risk zones.

    • Pass
    • Flag
    • Fail
  • 8.6.1

  • 8.7 Protective clothing in high-risk and high-care zones

  • 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 ensu

  • adequate segregation between dirty and cleaned clothes

    • Pass
    • Flag
    • Fail
  • adequate segregation between clothes for high-risk, high-care and low-risk areas etc

    • Pass
    • Flag
    • Fail
  • effective cleaning of the protective clothing

    • Pass
    • Flag
    • Fail
  • commercial sterilisation of the protective clothing following the washing and drying process

    • Pass
    • Flag
    • Fail
  • protection of the cleaned clothes from contamination until use (e.g. by the use of covers or bags).

    • Pass
    • Flag
    • Fail
  • 8.7.1

  • 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.

    • Pass
    • Flag
    • Fail
  • 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

    • Pass
    • Flag
    • Fail
  • 8.7.3