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.

Required skills

Required skills include:

evaluating and selecting appropriate test methods and/or 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 and/or 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 enterprise/regulatory requirements related to method selection

regulatory/licensing testing requirements

relative advantages/disadvantages of test methods for a range of testing situations

cost advantages/disadvantages of enterprise test methods

scientific/technical 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 and/or legal requirements for traceability

enterprise/regulatory 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 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