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Elements and Performance Criteria

  1. Prepare for the trial
  2. Participate in the trial
  3. Assess and report trial outcomes
  4. Maintain a safe work environment

Range Statement

This field allows for different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Standards, codes, procedures and/or workplace requirements

Standards, codes, procedures and/or workplace requirements include the latest version of one or more of:

Australian and international standards covering the requirements for the competence of testing and calibration laboratories, laboratory safety, quality and environmental management; sampling of materials and international system of units (SI)

national work health and safety (WHS) standards and codes of practice, national environmental protection measures, and national measurement regulations and guidelines

specific codes, guidelines and procedures, such as National Association of Testing Authorities (NATA) accreditation requirements, principles of good laboratory practice (GLP), Food Standards Australia New Zealand (FSANZ) Code and User Guides, Australian code of good manufacturing practice for medicinal products (GMP), and Therapeutic Goods Regulations 1009

workplace documents, such as standard operating procedures (SOPs); quality and equipment manuals; calibration and maintenance schedules; material safety data sheets (MSDS) and safety procedures; material, production and product/formulation specifications; production and laboratory schedules; workplace recording and reporting procedures; waste minimisation and safe disposal procedures; maps and site plans

workplace procedures for production trials

Product properties, process stages and unit operations involved in the trial

Product properties, process stages and unit operations involved in trials include, but are not limited to, one or more of:

classification of samples (screening and sieving)

milling

mixing

separation (distillation, sieves, filtration, solvent extraction and chromatography)

drying

concentrating

diluting

depositing (injecting, forming and extrusion)

retorting

cooling, freezing, refrigeration and heat transfer

closure (vacuum sealing)

weighing and packaging

materials handling and transport, and warehousing

Trial specifications

Trial specifications include, but are not limited to, one or more of:

product specifications

recipe/formulations

processing parameters

trial size, production target and timeline

trial schedule and resources required

required product samples and tests

analysis of relevant WHS, food safety and environmental hazards and controls

storage requirements

Safe work practices

Safe work practices include, but are not limited to, one or more of:

following all safety requirements on the production floor

ensuring access to service shut-off points

recognising and observing hazard warnings and safety signs

labelling of samples, reagents, aliquoted samples and hazardous materials

handling and storage of hazardous materials and equipment in accordance with labelling, MSDS and manufacturer instructions

identifying and reporting operating problems or equipment malfunctions

cleaning and decontaminating equipment and work areas regularly using workplace procedures

using PPE, such as hard hats, hearing protection, gloves, safety glasses, coveralls, gowns, body suits, respirators and safety boots

machinery guards

signage, barriers, flashing lights and traffic control

reporting abnormal emissions, discharges and airborne contaminants, such as noise, light, solids, liquids, water/wastewater, gases, smoke, vapour, fumes, odour and particulates, to appropriate personnel

WHS and environmental management requirements

WHS and environmental management requirements include:

· complying with WHS and environmental management requirements at all times, which may be imposed through state/territory or federal legislation. These requirements must not be compromised at any time

· applying standard precautions relating to the potentially hazardous nature of samples

accessing and applying current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health, where relevant

Performance Evidence

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

safely conducting routine production trials to adjust formulations or develop products and processes on at least two (2) occasions

analysing trial objectives and specifications and accurately determining resource requirements

liaising and communicating with production and laboratory personnel to ensure trials are organised and conducted efficiently

working efficiently within production constraints, priorities and pressures

monitoring critical process parameters and collecting reliable data and samples

testing product samples and analysing results

recognising, interpreting and reporting problems, atypical situations or unacceptable products

recommending product modifications and improvements

reporting trial outcomes in accordance with workplace procedures

safely operating, maintaining and storing equipment and materials in accordance with workplace procedures

minimising environmental impacts and safely collecting and disposing of waste

following workplace safety procedures and hazard control measures.

Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

terminology, principles and concepts relevant to the trial, such as the relationships between:

temperature and viscosity

friction, pressure and fluid flow

trial objectives, laboratory trial requirements, documentation and reporting requirements

recipes and formulations, technical specifications and quality parameters for trial products

effect on product properties of variations in recipes and formulations

product properties, process stages and unit operations involved in the trial

expected nature and condition of materials at each process stage

causes and remedies for common processing problems associated with trial products

sampling and test methods for trial products

hazards, work health and safety (WHS), food safety and environmental management procedures relevant to the trial.