Elements and Performance Criteria

The range of variables relates to the unit of competency as a whole. It allows for different work environments and situations that will affect performance.
Where reference is made to industry Codes of Practice, and/or Australian/international standards, it is expected the latest version will be used.
All operations must comply with relevant standards, appropriate procedures and/or enterprise requirements.

Test methods and procedures may be or have been prepared from
Australian and international standards, acts and regulations, such as -
AS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO 9000 series Quality management and quality assurance standards
AS 2830 Good laboratory practice
Food Standards Code 2002 Australia New Zealand and amendments
AS/NZS 2243 Safety in laboratories
Therapeutic Goods Act
National Measurement Act
Codes of Practice (such as GLP and GMP)
material safety data sheets (MSDSs)
standard precautions for handling hazardous and potentially infective biological materials
standard operating procedures (SOPs), in house methods
quality manuals, equipment and procedures manuals
calibration and maintenance schedules
enterprise recording and reporting procedures
production and laboratory schedules
material, production and product specifications.

Tests and procedures may be routine, infrequent, one-off', quantitative or qualitative and may be applied to
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 may include the
new or amended legislation, regulation, licensing, accreditation requirements
public, political, 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 include
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, availability of trained staff
cost
selectivity of method, range, accuracy, precision and acceptable uncertainty
whether it is appropriate/ethical to perform the test.
The selection of appropriate test methods and procedures will depend on balancing customer, enterprise and/or regulatory/licensing requirements with laboratory resources available (including skilled personnel).

Health, safety and environment
All operations to which this unit applies are subject to stringent health, safety and environmental (HSE) requirements, which may be imposed through State or Federal legislation, and these must not be compromised at any time. Where there is an apparent conflict between performance criteria and HSE requirements, the HSE requirements take precedence.
All operations assume the potentially hazardous nature of samples and require standard precautions to be applied. Users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council and State and Territory Departments of Health. All operations are performed in accordance with standard operating procedures.

The Evidence Guide describes the underpinning knowledge and skills that must be demonstrated to prove competence.
Critical aspects of competency

Competency must be demonstrated in the ability to perform consistently at the required standard. Candidates must be able to evaluate and select appropriate test methods and/or procedures to satisfy the range of testing situations normally encountered in the laboratory. In particular, the assessor should look to see that the candidate can:

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, linearity, selectivity, range, limit of detection and matrix characteristics in method selection
clearly document method selection procedure(s)
maintain records of published methods
follow OHS procedures and GLP.

Underpinning knowledge

Competency includes the ability to apply and explain:

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
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, in 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.

Assessment context and methods
This unit of competency is to be assessed in the workplace or simulated workplace environment.

The following assessment methods are suggested:

completion of selection brief or selection proficiency test
review of records completed by 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. Questioning techniques should suit the language and literacy levels of the candidate.

Interdependent assessment of unit

This unit of competency may be assessed with:

PMLORG600B Supervise laboratory operations in work/functional area.

Resource implications

Resources may include:

standard laboratory equipped with appropriate equipment and reagents
SOPs and test methods
appropriate Australian and international regulatory standards.

This competency in practice
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 procedure(s) 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.
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.

The seven key competencies represent generic skills considered for effective work participation. The bracketed numbering against each of the key competencies indicates the performance level required in this unit. These are stand-alone levels and do not correspond to levels in the Australian Qualifications Framework (AQF).
Level (1) represents the competence to undertake tasks effectively
Level (2) represents the competence to manage tasks
Level (3) represents the competence to use concepts for evaluating and reshaping tasks.
Communicating ideas and information
(3)

Collecting analysing and organising information
(3)

Planning and organising activities
(3)

Working with others and in teams
(2)

Using mathematical ideas and techniques
(3)

Solving problems
(3)

Using technology
(3)