The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of ability to:

prepare to work in a clean room environment through the correct application of required clothing and footwear

conduct work according to clean room work standards

follow hand washing procedures

exit room according to clean room standards

apply safe work practices and identify OHS hazards and controls.

Context of and specific resources 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, including 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.

Method of assessment

This unit should be assessed together with core units and other units of competency relevant to the function or work role.

Guidance information for assessment

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

Required skills

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, including following appropriate hand washing, disinfecting procedures and fitting gloves as required

conduct work in a manner appropriate to minimising risk of contamination, including 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

use oral communication skills/language competence to fulfil the job role as specified by the organisation, including questioning, active listening, asking for clarification and seeking advice from supervisor

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of:

purpose and conditions required in a clean room environment, including 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, including 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, such as pressure differences between the clean room and change room and knowledge of location of pressure gauges, and checking operating conditions of ventilation systems where required

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

occupational health and safety (OHS) hazards and controls, including 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

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Policies and procedures

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 Good Manufacturing Practice (GMP) codes apply and reference to food safety is replaced by GMP

Workplace information

Workplace information may include:

standard operating procedures (SOPs)

specifications

production schedules and instructions

manufacturers' advice

standard forms and reports

Clean room

A clean room refers to any environmentally graded work area

Multiple gowning processes

Multiple gowning processes may be required

Protective clothing and footwear

Protective clothing and footwear are fit for purpose and appropriate to a clean room environment