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 1000-1998 The international system of units (SI) and its application
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 ISO 10005:2006 Quality management systems - Guidelines for quality plans
AS/NZS ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment
AS/NZS ISO 14000 Set:2005 Environmental management standards set
AS/NZS ISO 9000 Set:2008 Quality management systems set
ISO 5725 Accuracy (trueness and precision) of measurement methods and results
ISO/IEC Guide 98-3:2008 Uncertainty of measurement - Part 3 Guide to the expression of uncertainty in measurement (GUM)
Eurachem/CITAC Guide CG4 Quantifying uncertainty in analytical measurement
Australia New Zealand Food Standards (ANZFS) Code
Australian code of good manufacturing practice for medicinal products (GMP)
Australian Dangerous Goods Code
Australian Quarantine and Inspection Service (AQIS) Export Control (Orders) Regulations 1982 and Import Guidelines
ethics committee requirements
gene technology regulations
intellectual property and copy right
material safety data sheets (MSDS)
material, production and product specifications
National Association of Testing Authorities (NATA) Accreditation programs requirements
national environment protection measures
National Health and Medical Research Council (NHMRC) Guidelines
national measurement regulations and guidelines
OHS national standards and codes of practice
principles of GLP
quality manuals, equipment and procedures manuals
Therapeutic Goods Regulations 1009
Tests and procedures
Tests and procedures may be:
routine
infrequent
'one-off'
quantitative or qualitative
identification or quantification of biological, chemical or physical activity
gross characteristics of a sample, including in vitro and in vivo
detection of chemical, physical or biological characteristics, features, markers or responses
Drivers for the evaluation and selection of test methods and/or procedures
Drivers for the evaluation and selection of test methods and/or procedures may include the:
new or amended legislation, regulation and licensing, accreditation requirements
public, political and commercial pressures
'one-off' testing of potentially hazardous or contaminated materials following an environmental emergency or incident
introduction of new reference standards, new or modified equipment and instruments
introduction of commercial products that are potentially hazardous
control of new, or changed, starting materials, in-process materials and products
troubleshooting of production, environmental and public health issues
environmental monitoring of new sites
investigation of customer's complaints
specialised testing of forensic, medical or veterinary samples
need to meet customer specific or changed requirements
development of new products
Factors which may influence method evaluation and selection
Factors which may influence method evaluation and selection
quantity and nature of sample available for testing
levels of detection required
type of matrix, possible contaminants and resulting interference
safety
availability of suitable equipment, instruments and availability of trained staff
cost
selectivity of method, range, accuracy, precision and acceptable uncertainty
whether it is appropriate/ethical to perform the test
balancing customer, enterprise and/or regulatory/licensing requirements
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:
evaluate and select appropriate test methods and/or procedures to satisfy the range of testing situations normally encountered in the laboratory
identify reference standards or SOPs appropriate to testing requirements of the laboratory
identify standards that support compliance with regulatory and/or licensing requirements
apply enterprise procedures to select appropriate standards
use method performance measures, such as accuracy, precision, uncertainty, linearity, selectivity, range, limit of detection and matrix characteristics in method selection
clearly document method selection procedures
maintain records of published methods
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:
MSL925002A Analyse measurements and estimate uncertainties
MSL916003A Supervise laboratory operations in work/functional area.
Resources may include:
standard laboratory equipped with appropriate equipment and reagents
SOPs and test methods
appropriate Australian and international regulatory standards.

Method of assessment
The following assessment methods are suggested:
completion of selection brief or selection proficiency test
review of records completed by the candidate over a period of time to confirm consistency in method selection
feedback from peers and supervisors
oral questioning to establish basis of selection of test methods and/or 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.
Biotechnology
The choice of analytical method for protein assay is influenced by the amount of protein likely to be present and the impurities present. During an extraction procedure, the yield of protein is monitored. At any stage there will be a range of substances used in the extraction. When the extraction is complete and the protein required has been isolated, the amount of protein recovered could range from bulk or gram quantities down to microgram quantities. The technical officer will check through the available methodologies and select procedures that will take account of the above problems. The Biuret assay is used for bulk assay protein, but will require reagent blanks to compensate for the impurities. At later stages of the monitoring, the Bradford reagent will be chosen because of its greater sensitivity and detection of smaller concentrations. It will be chosen over the Folins reagent because the Bradford reagent is not affected by buffer reagents and detergent.
Biomedical
A technician is asked to detect, identify and quantify a blood group antibody using a range of physical, chemical and immunological tests. During the test evaluation and selection process he/she identifies performance parameters, such as test tolerance, sensitivity, specificity and reproducibility along with the effect of possible interfering serum pigments, such as dissolved haemoglobin and bilirubin. The technician prepares a report for the supervising scientist that explains the selection rationale, reports the performance test results and cites product information and recent literature to validate the test results and substantiate his/her conclusions and recommendations.
Food processing
A technician working in a food company must be able to select test methods appropriate to requirements. For example, if a quick determination of unsaturation in an oil mixture is required, the technician will probably use an appropriate method for determining the iodine value of the mix and compare this with specification. However, at a margarine manufacturing plant where the technician may be required to perform an analysis of fats and oils to determine the % saturated, % monounsaturated and % polyunsaturated components, then a gas chromatographic method would be run using appropriate computer software and the results checked against specification.