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.
Codes of practice
Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used
Standards, codes, procedures and/or enterprise requirements
Standards, codes, procedures and/or enterprise requirements may include:
Australian and international standards, such as:
AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories
AS/NZS 2243 Set:2006 Safety in laboratories set
AS/NZS 2982.1:1997 Laboratory design and construction - General requirements
AS/NZS ISO 14000 Set:2005 Environmental management standards set
AS/NZS ISO 9000 Set:2008 Quality management systems set
AS ISO 1000-1998 The international system of units (SI) and its application
Eurachem/CITAC Guide CG4 Quantifying uncertainty in analytical measurement
Australian code of good manufacturing practice for medicinal products (GMP)
calibration and maintenance schedules
cleaning, hygiene and personal hygiene requirements
data quality procedures
enterprise procedures, SOPs and operating manuals
enterprise recording and reporting procedures
equipment startup, operation and shutdown procedures
incident and accident/injury reports
material safety data sheets (MSDS)
material, production and product specifications
national measurement regulations and guidelines
principles of GLP
production and laboratory schedules
quality manuals, equipment and procedure manuals
quality system and continued improvement processes
safety requirements for equipment, materials or products
sampling procedures (labelling, preparation, storage, transport and disposal)
schematics, work flows and laboratory layouts
statutory and enterprise OHS requirements
stock records and inventory
test procedures (validated and authorised)
training program contents
waste minimisation, containment, processing and disposal procedures
Routine chromatographic techniques
Routine chromatographic techniques include both analytical and preparative procedures, and may include:
standard sample introduction systems
paper such as ascending and descending
thin-layer such as ascending, high performance, radical and descending
column chromatography
affinity chromatography and gel filtration chromatography
gas liquid and gas solid chromatography
high performance liquid chromatography, such as liquid-liquid (LLC), liquid-solid (LSC), ion (IC) and size exclusion (SEC)
Tests
Tests may include methods for:
control of starting materials, in-process materials and finished products (e.g. manufacturing, petroleum and biotechnology)
selection of appropriate separation technique, such as suitable substrate and support solvent, buffer, temperature, flow rate, column length and detection method
forensic testing
environmental monitoring of pollutants in air, water and soil
troubleshooting enterprise processes
Sample preparation
Sample preparation may include:
identification of any hazards associated with samples and/or analytical chemicals
grinding, dissolving, extraction, filtration, refluxing, centrifuging, evaporation, washing and drying
determination of and, if appropriate, removal of any contaminants, impurities or interfering substances
Common procedure and equipment problems
Common procedure and equipment problems may include:
problems with interfering substances
poor resolution of peaks
inappropriate selection of column or operating parameters (flow rate and temperature)
unsuitable substrate or support solvent
lack of suitable reference standards
Hazards
Hazards may include:
electric shock
biohazards, such as microbiological organisms and agents associated with soil, air, water, blood and blood products, and human or animal tissue and fluids
transformed cultures/organisms and genetically altered organisms
chemicals, such as acids, phenol, benzene and ammonium persulphide
sharps and broken glassware
sources of ignition and hot surfaces, such as burners
aerosols from broken centrifuge tubes and pipetting
flammable liquids and gases (e.g. hydrogen)
cryogenics such as dry ice and liquid nitrogen
disturbance or interruption of services
Addressing hazards
Addressing hazards may involve:
use of MSDS
labelling of samples, reagents, aliquoted samples and hazardous materials
use of personal protective equipment, such as gloves, safety glasses and coveralls
use of fumehoods, direct extraction of vapours and waste gases
use of appropriate equipment, such as biohazard containers, laminar flow cabinets, Class I, II and III biohazard cabinets
use of Class PCII, PCIII and PCIV physical containment laboratories
handling and storage of all hazardous materials and equipment in accordance with labelling, MSDS and manufacturer's instructions
Occupational health and safety (OHS) and environmental management requirements
OHS and environmental management requirements:
all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time
all operations assume the potentially hazardous nature of samples and require standard precautions to be applied
where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health

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

Critical aspects for assessment and evidence required to demonstrate competency in this unit
Assessors should ensure that candidates can:
interpret client requests, test methods and procedures accurately
safely set up and shut down equipment using enterprise procedures
check calibration/qualification status of equipment
prepare standards and samples appropriately
install and maintain a variety of chromatographic columns
choose and optimise procedures and equipment settings to suit sample/test requirements
operate equipment to obtain valid and reliable data
make approved adjustments to procedures for non-routine samples
recognise atypical data/results
troubleshoot common procedure and equipment problems
apply theoretical knowledge to interpret data and makes relevant conclusions
record and report data/results in accordance with enterprise procedures
maintain security, integrity and traceability of samples and documentation
follow OHS procedures and principles of GLP.

Context of and specific resources for assessment
This unit of competency is to be assessed in the workplace or simulated workplace environment.
This unit of competency may be assessed with:
MSL925001A Analyse data and report results.
Resources may include:
standard laboratory equipped with routine chromatographic equipment, laboratory reagents and equipment
SOPs and test methods.

Method of assessment
The following assessment methods are suggested:
review of test data/results obtained by the candidate over time to ensure accuracy, consistency and timeliness of results
inspection of test records and workplace documentation completed by the candidate
feedback from peers and supervisors
observation of candidate applying a range of routine chromatographic techniques
oral or written questioning of chemical principles and concepts, chromatographic techniques and enterprise procedures.
In all cases, practical assessment should be supported by questions to assess underpinning knowledge and those aspects of competency which are difficult to assess directly.
Where applicable, reasonable adjustment must be made to work environments and training situations to accommodate ethnicity, age, gender, demographics and disability.
Access must be provided to appropriate learning and/or assessment support when required.
The language, literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment.

This competency in practice
Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting.
Manufacturing
Technicians who conduct chemical synthesis frequently use chromatographic methods such as thin-layer chromatography (TLC), gas chromatography (GC), high performance liquid chromatography (HPLC) and other instrumental techniques to check the identity and purity of the material they have produced. For example, a technician reacted an amine with acetic anhydride to form the acylated amine to prepare a pilot batch of material for a new application. After completing the reaction, the technician collected the product in a Buchner funnel using vacuum assisted filtration, and used chromatographic techniques to purify the material. The product was then analysed by HPLC using a number of stationary phases and solvent systems. In each case, a reference standard was run. These tests confirmed the identity and purity of the material.
Biotechnology
Technicians in research facilities often prepare a protein by extracting it from tissue. This extraction process introduces impurities that must be removed before the purified protein is ready for use or the characterisation of its purity and molecular weight. Impurities such as salt, detergents and other proteins are sequentially removed by passing the protein extract through gel filtration columns of differing grades of chromatographic gel. For antibodies, the final column used is an affinity chromatography column. Demonstration of the purity of the protein is by the presence of one single band on an SDS-PAGE gel. The molecular weight of the protein can also be determined from the SDS gel.
Environment
An environmental protection authority was required to sample an oil slick off Australia's coast and to take oil samples from all ships which docked in Australian ports in the 48 hours after the discovery of the oil slick. The samples were analysed by column chromatography and compared with the oil slick 'finger print' of the oil samples from all ships which may have been in the area of the oil slick. Given that the analysis involved unknown oil samples and the results would be used in court proceedings, the analysts were careful to optimise the chromatographic system for the unknown samples, ensure that appropriate quality and control procedures were employed and that the sample and analyses were performed quickly before potentially polluting ships left Australian waters. The analysts were careful to ensure that all record keeping procedures would be able to stand up to court scrutiny.