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 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
appropriate journals and Internet sites
Australia New Zealand Food Standards (ANZFS) Code
Australian code of good manufacturing practice for medicinal products (GMP)
Australian Quarantine and Inspection Service (AQIS) Export Control (Orders) Regulations 1982 and Import Guidelines
calibration and maintenance schedules
enterprise recording and reporting procedures
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 good laboratory practice (GLP)
production and laboratory schedules
quality manuals, equipment and procedures manuals
Therapeutic Goods Regulations 1009
New methods of analysis and related procedures
New methods of analysis and related procedures may be required to:
analyse raw materials
quality control or evaluate the stability of products
quality control or evaluate the stability of new formulations of existing products
use new technology
meet regulatory requirements
meet customer requirements
improve productivity
improve accuracy and precision
Analyses
Analyses may include:
non-instrumental methods, such as gravimetric, titrimetric and qualitative tests
spectrometric methods, such as ultraviolet-visible (UV-VIS), infra red (IR) (including fourier transform infra red (FTIR)), near infra red (NIR), atomic absorption (AA) and fluorescence
chromatographic methods, such as thin layer, paper, gas chromatography (GC), high performance liquid chromatography (HPLC), ion chromatography (IC) and electrophoresis
electrochemical methods, such as ion-selective electrodes and polarography
assays based on biological properties or cell properties for enzyme antibody activity
Procedures
Procedures are:
directions for conducting analyses
hard copy
online format
Concepts relating to method development
Concepts relating to method development include:
determining and defining development objectives
relating chemical and physical characteristic of sample to possible assay methods
evaluating criteria to choose appropriate analytical method
sample cleanup and preparation techniques
preparation, setup and calibration of testing equipment
choice of appropriate detection system ensuring accuracy/precision criteria are achieved
optimisation of analysis conditions
generating, recording and reporting data in format which assists procedure writing
Criteria for choice of method
Criteria for choice of method may include:
economic factors
safety considerations
resource factors, including equipment and personnel
regulatory, accreditation and registration considerations
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:
develop or adapt analyses and procedures to meet requirements
interpret a brief to determine testing requirements
apply theoretical concepts and practical principles to develop or adapt methods to meet requirements
evaluate existing testing procedures against new testing requirements
use appropriate procedures to research alternative methods
use method performance measures, such as accuracy, precision, uncertainty, linearity, selectivity, range, limit of detection and matrix characteristics
make recommendations for modification of existing procedures or development of new procedures based on sound principles
follow enterprise procedures to document and circulate new procedures.

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
MSL977001A Contribute to the development of products and applications
MSL977002A Troubleshoot equipment and production processes
MSL977003A Contribute to validation of test methods.
Resources may include:
standard laboratory equipped with appropriate equipment, reagents, samples and test methods
online data search facilities.

Method of assessment
The following assessment methods are suggested:
review of development or adaptation of methods completed by the candidate
review of workplace development briefs completed by the candidate
feedback from supervisors and/or clients
oral or written questioning to assess underpinning knowledge of analyses, instrument operation, procedures and problem solving techniques.
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
Technical specialists often have to apply their practical and theoretical knowledge of laboratory instrumentation to adapt or develop methods to solve specific problems. For example, a technical specialist in a consulting laboratory was asked to determine why heat-sealing bags were not sealing properly. Using infrared spectroscopy, the specialist ran spectra on several samples and noticed a difference in the coating on the bags which didn't seal compared with the coating on bags which sealed correctly. The spectra indicated that the coatings were different polymers. The technical specialist notified the supplier of the sealing problem and new bags were forwarded. To ensure that the problem didn't occur again, an infrared spectroscopy test method was developed to ensure that the correct polymer coating was on the new bags. As a result, production flowed smoothly when bags were delivered to the production line.
Biomedical
A laboratory manager determined that there is sufficient demand for a particular enzyme activity assay. Currently, this assay is performed manually by kinetic assay using a spectrometer. A senior technical officer has been given the task of converting the method to one that can be run on an automated biochemical analyser. The method will be translated to instructions regarding wavelength, absorbance increase or decrease, time of reading and intervals of the readings, sequence of addition of the reagents and sample, ratio of the volumes (they will be reduced in the automated procedure) and incubation conditions.
Food processing
The water activity of food is affected by temperature. The measurement of water activity takes considerable time, due in part to the time required for the sample to reach the specified test temperature in the instrument. A technician suggested that the test time could be reduced if the samples were presented to the instrument at the test temperature, rather than room temperature. She/he also raised concerns about water loss which could occur while raising the sample to test temperature. The technician planned an investigation and ran tests using standard Greenspan salts to compare results from normal testing with testing using pre-warm samples. Pre-warm samples held for 30 minutes in a pre-warm cabinet gave different results from the normal test method samples. However, samples held for 15 minutes in the pre-warm cabinet did not. A test method was subsequently introduced with samples being held for a maximum of 10 minutes in a pre-warm cabinet prior to being loaded into the water activity instrument. This gave excellent statistical correlation with the normal method and provided increased throughput of samples.