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.

Required skills

Ability to:

select, fit and use personal protective clothing and/or equipment, including gowning up, following required work area entry and exit procedures and moving around the work area to minimise risk of contamination

prepare equipment for operation, such as inspecting equipment condition to identify any signs of wear, disinfecting and sterilising equipment and surfaces, assembling columns, confirming that connections and valves are correctly positioned, ensuring column lines have been purged and all safety guards are in place and operational, selecting instrumentation settings, cancelling isolation or lock outs as required, and conducting pre-start checks to check equipment readiness

carry out sample testing to confirm integrity of columns (this is typically done by conducting a Height Equivalent to Theoretical Plate (HETP) test)

demonstrate procedure for loading/packing product into columns

start, operate, and monitor the process to achieve required outcomes, including monitoring:

chromatography cycles

correct collection of fractions as required

appropriate product segregation

pump operation

take corrective action in response to out-of-specification results

maintain security, integrity and traceability of samples, sub-samples and documentation

respond to and/or report equipment failure within level of responsibility

locate emergency stop functions on equipment

follow isolation and lock out/tag out procedures as required to take process and related equipment off line in preparation for cleaning and/or maintenance within level of responsibility

demonstrate product/process changeovers, including demonstrating column storage procedures

follow end of batch procedures including line clearance and cleaning, yield calculation, materials reconciliation and product labelling

complete workplace 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 principles of chromatography, including process, purpose and methods used for analysis and preparation

basic operating principles of chromatography equipment, such as main equipment components, consequences of incorrect equipment preparation (i.e. incorrectly positioned non-return valve, supply pump failure and air in the column)

quality characteristics and legal requirements to be achieved by the separation process

operating requirements and parameters and corrective action required where operation is outside specified operating parameters

typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems

sample test methods and action required if results are out-of-specification (i.e. action required if the HETP fails)

procedures to collect fractions as appropriate to columns and process requirements

procedures to identify traces as required and corrective action where traces are not within specification

typical profile for a product cycle and the events to be monitored during the cycle

procedures used to ensure product segregation

analysis and interpretation of relevant test results and implications for action required

GMP/Good Laboratory Practice (GLP) requirements associated with chromatography process and related control measures

common causes of variation and corrective action required

occupational health and safety (OHS) hazards and controls, including the limitations of protective clothing and equipment used

procedures and requirements of different shutdowns, including an understanding of the requirements for column storage, emergency and routine shutdowns and procedures to follow in the event of power outage

line clearance, cleaning and sanitation procedures

isolation, lock out and tag out procedures and responsibilities

procedures and responsibilities for reporting production and performance information

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