Staff Facilities for High-Risk and High-Care Zones Procedure

Control personnel entry through designated facilities

Where high-risk or high-care areas are operated, the procedure requires personnel to enter through a specially designated changing facility at the entrance to the area and separate from facilities used for lower-risk areas. Hand-washing and disinfection facilities form part of that arrangement, with their positioning defined according to whether the protected area is high-risk or high-care.

Department Managers and Supervisors are responsible for preventing bypass of the designated route. Where a required changing, hand-washing or disinfection facility is unavailable or cannot be used as intended, entry is restricted until the facility is restored or another specially designated facility meeting the applicable requirements is available.

Protect clean clothing through a controlled changing sequence

Technical or Quality Management establishes controlled changing instructions for each applicable entry. These define the sequence for changing into and out of dedicated protective clothing, incorporate hand-washing at the required points and maintain separation between protective clothing used in the protected area and clothing used elsewhere.

The changing-out sequence specifically requires outer protective clothing to be removed before personnel handle footwear or hair coverings, helping protect clean clothing during exit. Protective clothing for the high-risk or high-care area is visually distinct and is not worn outside the area for which it is designated.

Where the defined changing sequence cannot be completed, required protective clothing is unavailable or unsuitable, or the specified hand-hygiene controls cannot be applied, the procedure requires entry to remain restricted until the affected requirement can again be met.

Define and enforce dedicated-footwear boundaries

Footwear used for entry to a high-risk or high-care area is dedicated site footwear, provided by the site and not worn outside the factory. Technical or Quality Management defines any site-specific limits on where that footwear may be worn, with the applicable changing instructions identifying those boundaries where footwear is restricted to a defined area within the factory.

Department Managers and Supervisors enforce the defined boundaries and do not permit entry where suitable site-provided footwear is unavailable.

Select a defined footwear-control method for each entry point

Effective footwear control is required at each applicable high-risk or high-care entry point. Technical or Quality Management determines whether the control uses segregation with a controlled footwear change or controlled and managed boot-wash facilities, and supervisors ensure that the selected method is applied during routine entry.

Where controlled footwear change is used, dedicated footwear remains captive to the applicable area and the changing arrangements maintain separation between footwear used before the change and footwear used within the controlled area. The document requires the change point and footwear boundaries to be defined, with personnel completing the change before entry.

Where boot-wash facilities are used, they are located at the entrance to the applicable protected area. Their suitability is assessed by risk assessment, operating and sanitation conditions are defined, and effectiveness is demonstrated through microbiological validation that includes swabbing of footwear, floors and drains.

Verify footwear-control effectiveness during routine operation

Environmental monitoring is used to verify the continued effectiveness of footwear controls in high-risk and high-care areas. Technical or Quality Management identifies the locations to be monitored and reviews relevant results. Sampling frequencies, target organisms or indicators, test methods, limits and result-evaluation requirements are established through the Housekeeping & Hygiene Procedure rather than duplicated in this document.

Where monitoring does not verify continued effectiveness, Technical or Quality Management determines the assessment and action required to restore effective control. Department Managers and Supervisors restrict entry through the affected route until Technical or Quality Management confirms that the footwear control is again effective.

Respond to loss of footwear control and assess affected product

The procedure defines a clear response where the selected footwear control is unavailable, is not being applied as defined or cannot be demonstrated to remain effective. The affected entry is restricted, and Technical or Quality Management confirms restoration of effective control before routine use resumes.

Where a footwear-control failure occurs, Technical or Quality Management also assesses whether product may have been affected. Potentially affected product is controlled through the Non-Conforming Product Control Procedure, while repeated, significant or systemic failures requiring investigation or corrective action are managed through the Corrective & Preventive Action Procedure.

Allocate responsibility across technical, operational and engineering functions

Senior Management provides the resources and organisational support needed for the required facilities and personnel-entry controls. Technical or Quality Management owns the entry hygiene requirements, controlled changing instructions, footwear-control method, boot-wash suitability and effectiveness assessment, environmental-monitoring review and restoration decisions.

Department Managers and Supervisors enforce the defined entry, changing, hand-hygiene, protective-clothing and footwear requirements and restrict entry when controls are unavailable or ineffective. Facilities or Engineering Management maintains the supporting changing, hand-washing, disinfection and boot-wash infrastructure, while employees follow the designated route and apply the controls specified for each area entered.

A zone-specific personnel-entry procedure within the wider FSQMS

Within the wider FSQMS, this procedure interfaces with staff-facility management, maintenance, personal hygiene, protective clothing, housekeeping and hygiene, environmental monitoring, non-conforming product control and corrective action. Those interfaces keep this document focused on the additional entry, changing, hand-hygiene and footwear controls for high-risk and high-care areas while related procedures govern the supporting facility, hygiene, product-control and system requirements.