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Elements and Performance Criteria

  1. Perform scientific calculations
  2. Analyse trends and relationships in data
  3. Determine variation and/or uncertainty in data distributions
  4. Check for aberrant results
  5. Report results

Required Skills

Required skills

Required skills include

performing laboratory computations

calculating scientific quantities

statistical analysis

graphical analysis

reporting results in the required formats and expected timeframe

storing retrieving and manipulating data following document traceability procedures

maintaining the security and confidentiality of data in accordance with workplace and regulatory requirements

Required knowledge

Required knowledge includes

relevant scientific and technical terminology such as variables dispersion central tendency process control process stability normal distribution confidence level and replication

calculations involving evaluation of formulae containing algebraic power exponential andor logarithmic functions

preparation and interpretation on linear and nonlinear graphs complex control charts and frequency distribution plots

determination of regression line equations correlation coefficients

statistical analysis and significance tests such as ttest ftest analysis of variance ANOVA

data acceptability tests such as Q T and Youden

the characteristics of a valid measurement

relevanceimportance of the national measurement legislation and guidelines to laboratory measurement

sources and estimates of uncertainty in measurements

procedures for data traceability

procedures for verifying data and rectifying mistakes

procedures for maintaining and filing records and maintaining security of data

Evidence Required

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

MSLA Use laboratory application software

MSL924002A Use laboratory application software

technical units such as

relevant MSL series units of competency

relevant MSL 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 andor 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 candidates 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 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

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 ultravioletvisible UVVIS 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


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