Required skills

Required skills include

evaluating and selecting appropriate test methods andor procedures to satisfy the range of testing situations normally encountered in the laboratory

identifying reference standards or SOPs appropriate to testing requirements of the laboratory

identifying standards that support compliance with regulatory andor licensing requirements

applying enterprise procedures to select appropriate standards

using method performance analysis measures such as accuracy precision uncertainty linearity selectivity range limit of detection and matrix characteristics in method selection

documenting method selection procedures

maintaining records of published methods

following OHS procedures and principles of good laboratory practice GLP

Required knowledge

Required knowledge includes

principles concepts and enterpriseregulatory requirements related to method selection

regulatorylicensing testing requirements

relative advantagesdisadvantages of test methods for a range of testing situations

cost advantagesdisadvantages of enterprise test methods

scientifictechnical principles underpinning test method and their application to selection of testing methods for different materials

metrological principles

significance of normal physiological or reference ranges

enterprise andor legal requirements for traceability

enterpriseregulatory requirements regarding recording and reporting

relevant health safety and environment requirements

Specific industry

Additional knowledge requirements may apply for different industry sectors For example

Biomedical biotechnology and food processing

effects of biologically inert or active chemicals such as food and drug metabolites in test selection testing and test data interpretation

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 andor 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 andor 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

MSLA Analyse measurements and estimate uncertainties

MSL925002A Analyse measurements and estimate uncertainties

MSLA Supervise laboratory operations in workfunctional area

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 andor 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 andor 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 heshe 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 hisher 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

Codes of practice

Standards, codes, procedures and/or enterprise requirements

Tests and procedures

Drivers for the evaluation and selection of test methods and/or procedures

Factors which may influence method evaluation and selection

Occupational health and safety (OHS) and environmental management requirements