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
Eurachem/CITAC Guide CG4 Quantifying uncertainty in analytical measurement
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)
national measurement regulations and guidelines
National Association of Testing Authorities (NATA) Technical notes
material safety data sheets (MSDS)
equipment manuals and warranty, supplier catalogues and handbooks
sampling and test procedures and standard operating procedures (SOPs)
enterprise quality manual and customer quality plan
validation of the equipment and associated software, where applicable
validation of spreadsheets developed in-house for assay and process calculations
Data records
Data records may include:
worksheets
spreadsheets or databases linked to information management systems
the results of tests, measurements, analyses and surveys
Scientific and technical terminology
Scientific and technical terminology may include:
variables
dispersion
central tendency
process control
process stability
normal distribution
confidence level
replication
Laboratory computations
Laboratory computations may include:
algebraic, logarithmic, exponential and power functions
calculations involving fractions, decimals, ratios, proportions and percentages
evaluation of formulae containing powers, exponents and logarithms functions
use of scientific notation, correct units and correct number of significant figures
calculation of uncertainties
preparation and interpretation of linear, semi-log and log-log graphs
calculation and interpretation of statistical quantities, such as mean, median, mode, range, variance and standard deviation
determination of regression line equations and correlation coefficients
preparation and interpretation of more complex control charts and frequency distribution plots
Calculations of scientific quantities
Calculations of scientific quantities may include:
percentage and absolute uncertainties in measurements and test results
dose (mg), dilution(1:10), concentration (molarity, g/mL, mg/L, ppm, ppb)
pH, [H+], [OH-], buffer calculations, Ka, pKa, Kb, pKb, Kw
solubility constants Ks, pKs
radioactivity:
half life, dose, activity and exposure
optical properties:
absorbance/transmittance, path length, extinction coefficient, concentration (Beers law) and detection limits
electrical properties:
conductivity, resistivity and dielectric constants
mechanical properties:
stress, strain, elastic moduli, yield strength and hardness
thermal properties:
heat capacity, thermal expansion, thermal conductivity and thermal resistance
food content (%) of water, ash, dietary and crude fibre, carbohydrate, protein, fat and specific vitamin
quantities associated with quality control monitoring, assessment and reporting
Graphical analysis
Graphical analysis may include:
determination of linear, logarithmic, exponential and power relationships
regression lines and interpretation of correlation coefficients
preparing frequency distributions for given data
calculating and interpreting measures of central tendency and dispersion
Calculations
Calculations may be performed:
with a calculator
without a calculator
with computer software such as:
spreadsheets
databases
statistical packages
Statistical analysis
Statistical analysis may include the use of:
histograms, frequency plots, stem and leaf plots, boxplots and scatter plots
probability and normal probability plots
Pareto diagrams, Stewhart control charts and CuSum control charts
regression methods for calibration, linearity checks and comparing analytical methods
analysis of variance (ANOVA)
data acceptability tests, such as Q, T and Youden
Records
Records may include information associated with:
purchase of equipment and materials
service records
safety procedures
history of calibration and test results
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:
store, retrieve and manipulate data following document traceability procedures
calculate scientific quantities relevant to their work and present accurate results in the required format
analyse data to determine relationships between variables
prepare frequency distributions for given data, calculate and interpret measures of central tendency and dispersion
prepare and interpret control charts and take appropriate actions
maintain the security and confidentiality of data in accordance with workplace and regulatory requirements
report results in the required formats and expected timeframe.

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:
MSL924002A Use laboratory application software
technical units, such as:
relevant MSL974000 series units of competency
relevant MSL975000 series units of competency.
Resources may include:
data sets and records
computer and relevant software or laboratory information system
relevant workplace procedures.

Method of assessment
The following assessment methods are suggested:
review of data worksheets, calculations, computer files (such as spreadsheets, databases), statistical analysis, graphs and/or tables prepared by the candidate
questions to assess understanding of relevant procedures, trends in data and sources of uncertainty
review of reports prepared by the candidate
feedback from supervisors and peers regarding the candidate's ability to analyse and report data in accordance with enterprise 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.
Manufacturing
Before pharmaceutical products can be approved for use in Australia, they must be tested for shelflife in their Australian sales packs. The shelf life of a preparation is the time of storage which results in a preparation becoming unfit for use, either through chemical decomposition of the active substances or physical deterioration of the preparation. Stability profiles are determined by storing the preparation under a range of temperature conditions and evaluating it at predetermined time intervals. For example, a technical assistant may be required to evaluate the physical parameters of the new tablet to detect any changes in its appearance, hardness, friability, disintegration and dissolution profile. The assistant regularly assays the tablets using a stability indicating assay. The results are plotted and the information gained is used to predict the period of time for which the tablets will meet the appropriate standards for physical characteristics, purity and potency when stored under defined conditions.
Biomedical
Supplementation of vitamins and minerals in the diet as a means to avert a clinical problem is a popular area of research, linking epidemiological and clinical investigation with food analyses. In the example of folate, such combined studies have led to the fortification of a number of foods and the requirement for folate supplementation for women of child bearing age. A typical project team would involve medical staff, a dietician and a scientific or technical officer to perform the assays. One possible line of study is to control the level of supplementation for the person and introduce the micronutrient in a dose form over and above that given in a controlled baseline diet. Blood samples would be collected and the serum micronutrient levels assayed. The technical officer would be responsible for keeping the statistical quality control data and analysing the assays. The technical officer would work with the research team to correlate the serum levels with the dose input. To contribute effectively, the technical officer must understand the significance of the relationships between collected test data and the controlled experimental variables.
Food processing
A state government analytical laboratory recently performed comparative assays of (-carotene using ultraviolet-visible (UV-VIS) spectrometric and high performance liquid chromatography (HPLC) techniques. In any procedure where the assay is to be replaced, side by side analyses must be performed on multiple samples and the correlations between the data compared statistically. The two procedures are then developed or modified for local laboratories and a routine procedure developed. At this point, technical officers would assay the samples by the two methods. They would ensure that all procedures were followed with close attention to quality control. Precision would be assessed through frequent assays of the same samples. Sensitivity of the assay would be assessed by performing the assay over a range of sample concentrations. The technical officers would carefully document the procedures and record all data for later validation. They may also provide preliminary graphical representations of data for their supervisor.