Housekeeping & Hygiene in High-Risk and High-Care Zones Procedure

Base cleaning requirements on the microbiological risk of each zone

The procedure requires high-risk and high-care cleaning requirements to be based on the documented cleaning risk assessment established under the Housekeeping & Hygiene Procedure. Technical / Quality Management ensures that the assessment considers the different microbiological risks associated with each applicable production risk zone and that the resulting methods and frequencies reflect those risks.

Those requirements are carried into controlled cleaning instructions for buildings, plant and equipment. For processing equipment and food-contact surfaces, the instructions identify the responsibility, item or area, frequency, method, cleaning chemicals and concentrations, cleaning materials or equipment, completion or sign-off requirement and responsibility for verification.

Where a required cleaning instruction, method or frequency is unavailable or cannot be applied as defined, Hygiene Management prevents the affected area or equipment from being accepted as satisfactorily cleaned until the required control can again be applied.

Use defined performance limits to govern acceptance and re-cleaning

Cleaning performance is assessed against predetermined criteria that distinguish acceptable results from those requiring further action. Technical / Quality Management defines acceptable and unacceptable microbiological limits for each applicable high-risk and high-care production risk zone from the hazards relevant to the product or processing area, and reviews those limits when the relevant hazards change.

Verification criteria and methods are selected according to risk and may include visual assessment, ATP bioluminescence, microbiological testing, chemical testing or another suitable means. Where results fall outside the acceptable limits, the procedure requires additional cleaning and re-verification until the defined limits are achieved. Hygiene Management ensures that the affected area or equipment is not accepted as satisfactorily cleaned before acceptable performance has been demonstrated.

Technical / Quality Management determines whether wider corrective action is needed in light of the result, the verification method and the applicable performance limits. Where a failure may have affected product, potential product impact is assessed and potentially affected product is controlled through the Non-Conforming Product Control Procedure. Repeated, significant or systemic cleaning failures are managed through the Corrective & Preventive Action Procedure where investigation or corrective and preventive action is required.

Validate cleaning and disinfection when it controls a specific hazard

Where cleaning and disinfection form part of a prerequisite programme used to control a specific hazard, the procedure requires validation before the defined method and frequency are relied upon for that purpose. Technical / Quality Management validates that the specified method can consistently achieve the required level of control and, where cleaning chemicals and concentrations form part of the method, that they are suitable for achieving the required cleaning performance.

Validation also includes assessment of the risk from cleaning-chemical residues on food-contact surfaces, with the evidence determined according to risk. A method is not approved for use within the prerequisite programme where validation has not demonstrated the required effectiveness; it must first be revised and satisfactorily validated. The cleaning frequency is also validated to show that the interval between cleaning activities provides the required hazard control, with revision and further validation required where the proposed frequency is not supported.

Keep cleaning equipment dedicated, hygienically suitable and controlled

Cleaning equipment used in high-risk and high-care areas is controlled through identification, area dedication, hygienic suitability, cleaning and storage. Technical / Quality Management defines a visually distinctive means of identification, the area to which equipment is dedicated and the hygienic-design requirements. Hygiene Management controls routine use, fitness for purpose, cleaning and hygienic storage.

Dedicated cleaning equipment remains within its designated high-risk or high-care area unless it cannot be effectively cleaned there. Where temporary removal is necessary, Hygiene Management controls its removal and return so that contamination is not introduced into the protected area.

The procedure also defines when equipment must be removed from use. Equipment that cannot be clearly identified as dedicated, has been used outside its designated area, is contaminated, is unsuitable for its intended use or has not been stored hygienically remains out of use until the issue has been corrected or suitable dedicated equipment is available. Where technical assessment is required, Technical / Quality Management confirms acceptability before the equipment returns to use.

Separate dedicated CIP and control shared CIP across risk zones

CIP controls depend on whether equipment is dedicated to one production area or a shared system serves more than one production risk zone. In either arrangement, the procedure requires the equipment and system to be controlled so that they do not present a contamination risk to the high-risk or high-care area.

Dedicated CIP equipment must remain separate and serve only the production area for which it is provided. Where that dedicated use cannot be demonstrated, Engineering Management prevents use until dedication has been restored, and Technical / Quality Management confirms that the restored arrangement does not present a contamination risk before routine use resumes.

For shared CIP systems, the procedure requires system design and routine operation to prevent contamination being transferred into high-risk or high-care areas. Flow is controlled from high-risk and high-care areas towards lower-risk production areas, and cleaning chemicals, cleaning solutions and rinse solutions are not recycled or reused from one production risk area to another. Technical / Quality Management confirms the design provides the required protection before the shared arrangement is relied upon.

Where defined flow direction, separation or solution-reuse controls cannot be maintained or demonstrated, the affected CIP operation is stopped. Engineering Management restores the required condition and Technical / Quality Management confirms that the shared arrangement no longer presents a contamination risk before routine use resumes.

Allocate responsibility across technical, hygiene and engineering functions

The procedure separates technical authority from routine implementation and equipment control. Senior Management provides the resources needed to support the high-risk and high-care cleaning, cleaning-equipment and CIP controls. Technical / Quality Management establishes technical requirements, performance limits and verification criteria, validates specific-hazard cleaning and disinfection, assesses potential product impact following cleaning failures, and confirms technical acceptability where required.

Hygiene Management ensures cleaning is completed at the defined frequency and to the applicable controlled instructions, manages additional cleaning and re-verification after unacceptable results, and controls the identification, dedication, condition, cleaning and storage of cleaning equipment. Engineering Management is responsible for dedicated-use controls, shared-system design and restoration of required flow, separation or solution-reuse controls following loss of control. Hygiene Operatives carry out cleaning and may operate CIP equipment in accordance with the applicable controls; Production Operatives operate CIP equipment where assigned. All employees are required to follow the controls relevant to their work.

A zone-specific hygiene procedure within the wider FSQMS

This procedure is deliberately bounded by related FSQMS controls. The Housekeeping & Hygiene Procedure governs the documented cleaning risk assessment, detailed cleaning methods and general CIP operation, monitoring, validation and maintenance. Equipment purchasing specifications and general procurement controls sit under the Equipment Management Procedure.

Where abnormal cleaning or CIP results may affect product, the procedure connects the technical assessment with non-conforming product control; repeated, significant or systemic failures interface with corrective and preventive action. Training for personnel involved in defining, approving, verifying, implementing, monitoring, maintaining or operating these controls is managed through the Training & Competence Procedure.