Personal Hygiene Procedure

Set production-area hygiene conditions before work begins

Personal hygiene requirements are communicated before personnel enter production areas or begin work. Department Managers or Supervisors are responsible for ensuring employees and agency-supplied personnel understand the requirements that apply to their work, while visitors and contractors receive the relevant hygiene requirements through the site-entry arrangements governed elsewhere in the FSQMS.

The procedure defines production-area rules for watches and similar wearable devices, jewellery, exposed rings and studs, fingernails, false nails and nail art, and excessive perfume or aftershave. Where personnel have not received or do not understand the applicable requirements, access or work is restricted until those requirements have been communicated.

Build hand hygiene into routine production

Hand-washing is required whenever personnel enter a production area and is repeated at a frequency appropriate to the activity and whenever necessary to minimise contamination risk, including when hands become dirty. Department Managers or Supervisors monitor compliance within the areas under their control.

The procedure keeps this behavioural control distinct from the facilities that support it. Provision, location and condition of hand-washing facilities are governed by the Staff Facilities Management Procedure, while additional entry and hand-hygiene controls for high-risk or high-care areas sit within the dedicated high-risk and high-care staff-facilities procedure.

Control cuts, grazes and site-issued plasters

Cuts or grazes on exposed skin must be covered by a site-issued plaster before a person enters or continues working in production. The procedure requires plasters to be readily identifiable, different in colour from the product being handled or manufactured, and fitted with a metal-detectable strip; blue is preferred where suitable.

Plaster issue is controlled and recorded. Department Managers or Supervisors ensure issued plasters remain accounted for throughout the period of use and decide when a glove is required as additional protection. If an issued plaster is lost, cannot be accounted for or no longer provides the required protection, the affected activity is restricted or stopped and Technical or Quality Management is notified where product may have been affected.

Verify plaster batches where metal detection equipment is used

Where the site uses metal detection equipment, the procedure adds a specific plaster-batch verification control. Metal Detector Operators or Quality Assurance personnel pass a sample from each plaster batch through the available detector and confirm successful detection, with the result recorded and maintained.

If successful detection cannot be demonstrated, the affected plaster batch is treated as non-conforming product. The procedure also preserves an important boundary: operation and routine verification of the metal detection equipment itself remain governed by the Foreign Body Detection & Removal Equipment Procedure, and the plaster-batch verification requirement does not apply where the site does not use metal detection equipment.

Manage personal medicines against contamination risk

Personal medicines are normally kept with personal belongings outside production areas. Where an individual has a genuine need to retain medicine with them, the Department Manager or Supervisor may permit this and must inform Technical or Quality Management.

Technical or Quality Management determines whether additional restrictions or controls are needed where the medicine or its proposed use could present a contamination risk. Where retention has been permitted, the medicine is kept in accordance with the conditions under which that permission was given for as long as the need remains.

Monitor compliance and respond when control is lost

Compliance is checked routinely throughout operations. Department Managers or Supervisors provide day-to-day monitoring, while Quality Assurance Technicians include documented personal hygiene checks within GMP inspections and record the outcome.

Any identified non-compliance must be corrected. Where a requirement cannot be met immediately, the individual is not permitted to enter or continue working in the affected production area until the requirement is met. Where a hygiene failure may have affected product, Technical or Quality Management ensures the potentially affected product is assessed and controlled through the Non-Conforming Product Control Procedure.

Repeated or significant hygiene failures that indicate a need for investigation, root cause analysis or systemic corrective action are managed through the Corrective & Preventive Action Procedure. This distinguishes routine correction of an immediate hygiene issue from the wider investigation needed where the pattern or significance of failure warrants it.

Allocate responsibility across hygiene control

Senior Management provides the resources and organisational arrangements needed to support personal hygiene, plaster control and hygiene monitoring. Technical or Quality Management maintains the procedure so its requirements remain appropriate to the products produced, decides whether additional medicine controls are needed, and oversees product assessment where hygiene failure may have jeopardised safety, quality or legality.

Department Managers or Supervisors communicate requirements, monitor day-to-day compliance, control plaster issue and use, make decisions on additional glove protection and permitted medicine retention, and prevent entry or continued work when requirements are not met. Quality Assurance Technicians provide documented GMP verification, while Metal Detector Operators or Quality Assurance personnel complete plaster-batch verification where applicable. Personnel subject to the procedure are responsible for complying with the hygiene, hand-washing, plaster and medicine controls that apply to them.

Connect personal hygiene with the wider FSQMS

The procedure is designed to operate with supporting controls rather than duplicate them. Document control governs approval and issue; training and competence arrangements govern delivery and training records; staff-facilities procedures govern hand-washing and personal-belongings facilities; protective-clothing controls cover glove requirements; record-control arrangements govern completion and maintenance of the evidence generated.

Where hygiene failures may affect product or indicate a wider systemic issue, the procedure interfaces with non-conforming product control and corrective and preventive action. These defined boundaries keep personal hygiene responsibilities clear while linking the procedure to the wider controls needed to manage facilities, evidence, product status and improvement.