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 activities are carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements
Legislative requirements
Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:
legislative and licensing requirements
Therapeutic Goods Act
weights and measures legislation
legislation relating to OHS, environmental management, equal opportunity and affirmative action, industrial awards and agreements
Workplace documentation
Workplace documentation relevant to work area activities include:
specifications
manufacturing formulae
processing instructions
batch production records
standard operating procedures (SOPs)
OHS information including material safety data sheets (MSDS)
Equipment
Chromatography equipment includes:
columns
flow meters
UV meters
filters and air sensors
Methods may include:
ion exchange
gel filtration
size exclusion filtration

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:
perform sample testing to confirm integrity of columns
start up, operate and monitor chromatography process to ensure separation of solutions to meet specifications
maintain all necessary records.

Context of and specific resources for assessment
Assessment must occur in a real or simulated workplace where the assessee has access to:
workplace documentation relating to separation process and procedures
chromatography equipment
typical range of samples to be tested
personal protective clothing and equipment
work procedures including advice on safe work practices, food safety, quality and environmental requirements.

Method of assessment
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.
Assessment of this unit would typically involve observation of the operator preparing, operating and shutting down the separation process to meet production requirements. Observation should be sufficient to confirm consistent performance.

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.