Elements and Performance Criteria

Range description
Work is carried out according to company policies and procedures, licensing requirements, legislative requirements, and industrial awards and agreements. When applied to the pharmaceutical industry, relevant GMP codes apply and reference to food safety is replaced by GMP
Workplace information may include Standard Operating Procedures (SOPs), specifications, production schedules and instructions, manufacturers' advice, standard forms and reports
A clean room refers to any environmentally graded work area
Multiple gowning processes may be required
Protective clothing and footwear are fit for purpose and appropriate to a clean room environment

Ability to:
Access workplace information to determine clean room work requirements
Confirm that protective clothing and footwear are appropriate for use
Follow procedures to fit and inspect protective clothing and footwear
Follow procedures to enter a clean room environment. This includes following appropriate hand washing and disinfecting procedures and fitting gloves as required
Conduct work in a manner appropriate to minimising risk of contamination. This includes following procedures for sterilising and disinfecting equipment and surfaces as required
Exit the clean room environment according to workplace procedures
Remove protective clothing and footwear in correct sequence and deposit for laundering according to workplace procedures
Complete records as required
Maintain work area to meet housekeeping standards

Knowledge of:
Purpose and conditions required in a clean room environment. This includes an understanding of how the clean room maintains a clean environment and related airflow systems
Preparation and handling requirements for garments and footwear worn in a clean room environment. This includes an understanding of garment features appropriate to a clean room environment and inspection procedure to confirm clothing and footwear are fit for use prior to fitting
Inspection points to confirm that clothing and footwear are correctly fitted according to workplace procedures
Procedures to follow if garments are not fit for use
Clean room control measures and related monitoring requirements. This may include pressure differences between the clean room and change room and knowledge of location of pressure gauges. It may also involve checking operating conditions of ventilation systems
Entry procedures
Requirements for conducting work in a clean room and consequences of not complying with these requirements. Typically work is conducted slowly to minimise disturbance of particulates
Procedures to follow to minimise risk of contamination including cleaning, sanitation, sterilisation and disinfecting of equipment and surfaces
Conditions which can cause contamination, and control measures to avoid this occurring
OHS hazards and controls. This includes awareness of the limitations of protective clothing and equipment relevant to the work process
Procedures for exiting and de-gowning
Laundering requirements and procedures
Housekeeping requirements for work area
Recording requirements and procedures

Relationship with other standards
Pre-requisite units

The pre-requisite unit for this competency standard is:

FDFCORFSY2A Implement the food safety program and procedures
or
FDFPHGMP2A Implement Good Manufacturing Practice procedures
Co-assessment of related units
This unit should be assessed together with core units and other units of competence relevant to the function or work role.

Resources required for assessment

Assessment must occur in a real or simulated workplace where the assessee has access to:

Protective clothing, footwear and equipment appropriate to a clean room
Work procedures relevant to working in a clean room environment. This includes those specific to entering and exiting the clean room and to carrying out the relevant work function
A clean room environment
Documentation and recording requirements and procedures

Assessment requirements
For information on how to assess this competency standard and who can assess, refer to the Assessment Guidelines for this Training Package.