Protective Clothing in High-Risk and High-Care Zones Procedure

Validate laundering before high-risk or high-care clothing is used

Protective clothing for high-risk and high-care areas is laundered only through an approved contracted laundry or an approved in-house laundry. Technical / Quality Management defines the criteria for laundering effectiveness and confirms, using objective evidence, that the selected process meets those criteria before it is used.

Validation covers effective cleaning, segregation, commercial sterilisation and protection of cleaned clothing. The approved process must keep dirty and cleaned clothing segregated and also keep clothing assigned to high-risk, high-care and low-risk areas segregated from the other production risk zones throughout laundering. Following washing and drying, the validated process is required to achieve commercial sterilisation, with cleaned clothing then protected from contamination during handling, transport, storage and issue until use.

Apply the validated requirements to contracted and in-house laundries

Where a contracted laundry is used, the applicable service agreement or specification communicates the validated laundering requirements for high-risk and high-care protective clothing. Approval and ongoing monitoring of the service provider remain governed by the Supplier & Raw Material Approval and Performance Monitoring Procedure, while Technical / Quality Management reviews evidence used to demonstrate laundering effectiveness as part of validation and ongoing review.

Where laundering is carried out in-house, the validated requirements are translated into controlled laundering instructions defining the operating conditions needed to maintain the approved process. Personnel carrying out the laundering follow the current instructions, and Technical / Quality Management reviews effectiveness evidence where required to confirm that the validated process continues to achieve the defined criteria.

Audit laundering controls at a frequency based on risk

Each contracted or in-house laundry used for high-risk or high-care clothing is audited directly by the site or by a suitable third party. Technical / Quality Management determines the audit frequency on the basis of risk and reviews the outcome to determine whether the required laundering controls remain effective.

For contracted laundries, the required laundry audit remains distinct from supplier approval and other service-provider monitoring activities. For in-house laundries, the laundry is included within the internal audit programme at the risk-based frequency established for it.

Where an audit does not demonstrate that the required laundering controls remain effective, Department Managers / Supervisors prevent affected clothing from being issued or used until Technical / Quality Management confirms that the required controls have been restored.

Restrict visibly dirty clothing and review recurring laundering concerns

Protective clothing returned from laundering that is visibly dirty is not issued or used and is returned for laundering. Affected clothing remains restricted from use until it has been re-laundered through the approved process.

Where repeated or significant instances of visibly dirty clothing are identified after laundering, Technical / Quality Management reviews the laundering arrangements and determines whether further action is required. If a laundering failure may have affected product, potentially affected product is controlled through the Non-Conforming Product Control Procedure; repeated, significant or systemic failures requiring investigation, root cause analysis or corrective and preventive action are managed through the Corrective & Preventive Action Procedure.

Set protective-clothing change frequencies through documented risk assessment

Technical / Quality Management determines the change frequency for high-risk and high-care protective clothing through a documented risk assessment, taking account of the clothing type, work area, product and activity as relevant. The defined frequency is recorded in the applicable controlled protective-clothing requirements or changing instructions.

High-risk and high-care protective clothing is changed at least daily, and hairnets are also changed whenever removed. Department Managers / Supervisors ensure the defined frequencies are followed in their areas, while personnel change clothing when a change is due.

The document keeps this risk-based change-frequency control separate from general replacement requirements for clothing that becomes soiled, contaminated, damaged or otherwise unsuitable, and from the detailed changing sequences and personnel-entry controls for high-risk and high-care areas. Those requirements are governed by the Protective Clothing Procedure and the Staff Facilities for High-Risk and High-Care Zones Procedure respectively.

Allocate technical, supervisory and operational responsibility

Senior Management provides the resources and organisational arrangements needed for validated laundering, laundry auditing, protective-clothing availability and change-frequency controls. Technical / Quality Management owns the validation criteria and technical laundering requirements, reviews laundering-effectiveness evidence and audit outcomes, determines audit frequency and sets risk-based clothing-change frequencies.

Department Managers / Supervisors control issue and use where visibly dirty clothing or ineffective laundering controls are identified and ensure change frequencies are followed. Personnel carrying out in-house laundering work to the current controlled instructions and maintain the defined laundering conditions, while all employees comply with the protective-clothing requirements applicable to the high-risk or high-care areas in which they work.

Connect garment hygiene with the wider FSQMS

The procedure provides a defined interface between protective-clothing hygiene and the wider controls that support high-risk and high-care operation. Contracted-laundry approval and monitoring, internal audit, non-conforming product control, corrective and preventive action, general protective-clothing replacement and personnel-entry controls remain governed by their dedicated procedures rather than being absorbed into this document.

For technical and operational teams, this gives a clear framework for establishing and checking the laundering process itself while preserving the separate authority and response mechanisms of the wider FSQMS.