Equipment & Maintenance in High-Risk and High-Care Zones Procedure

Maintain segregation while maintenance is carried out

Engineering Management is required to ensure that maintenance within high-risk and high-care areas is planned and carried out so that the segregation requirements established for the area are maintained throughout the work. Where normal segregation arrangements cannot be maintained, Engineering Management defines the alternative controls needed for the proposed activity, with Technical / Quality Management confirming their adequacy where food-safety or hygiene judgement is required.

The work cannot begin until the required controls are in place and the applicable segregation requirements can be maintained. This creates a defined decision point before maintenance proceeds when the normal zone arrangements are disrupted.

Maintenance tools and equipment are dedicated to the applicable high-risk or high-care area wherever possible, made identifiable and, wherever possible, retained within that area. Specialist or non-dedicated tools, and dedicated tools or equipment that have been removed and are to return, move into the procedure’s introduction and reintroduction controls before entry.

Control introduction and reintroduction before equipment enters the zone

For specialist, non-dedicated or returning tools and equipment, Engineering Management determines the controls required before entry or re-entry and ensures that work instructions and cleaning instructions are established. The applicable instructions are followed before entry, and the required hygiene clearance is completed and recorded.

Equipment being accepted back after removal is subject to additional controls. General movement, storage and reintroduction remain governed by the Equipment Management Procedure, while maintenance or repair and post-maintenance hygiene clearance remain governed by the Maintenance Management Procedure. Where hygiene clearance uses swabbing, on-site testing or laboratory analysis, the applicable testing method is controlled through the relevant inspection and analysis procedure.

The procedure does not allow equipment to be accepted back into a high-risk or high-care area until hygiene clearance has confirmed that it is clean and that contamination hazards have been removed. Where the required hygienic condition is not achieved, cleaning and hygiene-clearance activities are repeated before the equipment is presented again for acceptance. When return follows maintenance or repair, Operations Management also completes the required post-maintenance inspection and acceptance, and acceptance back into the area is recorded.

If failure of equipment hygiene or acceptance controls may have affected product, the procedure connects the response to the Non-Conforming Product Control Procedure. That preserves the distinction between deciding whether equipment is hygienically acceptable for return and controlling product that may have been affected.

Use defined control routes for portable and battery-charging equipment

Portable equipment, handheld devices and battery-charging equipment are brought under a specific decision by Technical / Quality Management before introduction into a high-risk or high-care area. The applicable control route is determined for the equipment or equipment type before use.

The procedure provides two routes: the equipment is either visually distinctive and dedicated to the applicable area, or it is managed through specific work instructions and/or cleaning instructions that define the controls required before introduction, movement or use. Where cleaning or hygiene clearance forms part of that second route, the relevant hygiene requirements apply before introduction or reintroduction.

Operations Management keeps visually dedicated equipment identifiable and prevents its use outside the conditions established for that dedication. Where the required dedication or specific contamination-control requirements cannot be demonstrated, the equipment is not used in the high-risk or high-care area until the applicable requirements are met again.

Allocate authority across maintenance, hygiene and operations

Responsibility is divided across the functions that resource, determine and apply the controls. Senior Management provides the resources and organisational arrangements needed for maintenance, segregation, hygiene-clearance, equipment-entry and acceptance activities to be completed before affected work or equipment use proceeds.

Technical / Quality Management provides the food-safety or hygiene judgement needed for alternative segregation arrangements and determines the controls for portable and battery-charging equipment. Engineering Management owns the zone-specific maintenance, dedication and entry or re-entry controls and establishes the necessary work and cleaning instructions. Operations Management completes post-maintenance inspection and acceptance where required and maintains the control of visually dedicated portable equipment.

Employees and other personnel working on behalf of the company are required to follow the segregation, equipment-use, work-instruction, cleaning and hygiene-clearance controls relevant to their activities and to report conditions where required controls cannot be maintained or demonstrated.

Build competence around the control points

Personnel who plan, determine, implement, follow, verify, inspect, accept or maintain these controls are required to be trained in the requirements relevant to their activities. The training scope includes responsibilities for maintenance and equipment controls, correct application of segregation and hygiene requirements, and recognition of situations that require additional controls, restriction of work or equipment use, technical or hygiene judgement, or escalation.

This keeps competence aligned with the roles that make or act on the procedure’s key decisions, including maintenance planning, hygiene clearance, equipment acceptance and the control of portable equipment.

A zone-specific procedure within the wider FSQMS

The procedure provides the high-risk and high-care layer of control around engineering intervention and equipment use. It interfaces directly with the High-Risk, High-Care & Ambient High-Care Segregation Procedure, Maintenance Management Procedure and Equipment Management Procedure, while detailed cleaning, hygiene-clearance methods, testing methods, document control, record control and non-conforming product requirements remain governed by their respective procedures.

For technical, quality, engineering and operations teams, that structure makes the boundary clear: this document defines the additional controls needed because the work or equipment enters a protected production zone, while the wider FSQMS procedures continue to govern the underlying maintenance, hygiene, equipment and evidence processes.