Elements and Performance Criteria

RANGE STATEMENT
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

EVIDENCE GUIDE
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.