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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 17025-2005 General requirements for the competence of testing and calibration laboratories AS/NZS ISO 9000 Set:2008 Quality management systems set Australia New Zealand Food Authority (ANZFA) Code and User Guides Australia New Zealand Food Standards (ANZFS) Code Australian code of good manufacturing practice for medicinal products (GMP) calibration and maintenance schedules enterprise recording and reporting procedures equipment startup, operation and shutdown procedures material safety data sheets (MSDS) material, production and product specifications principles of good laboratory practice (GLP) production and laboratory schedules quality, equipment and procedures manuals standard operating procedures (SOPs) Therapeutic Goods Regulations 1009 |
Product properties, process stages and unit operations involved in the trial | Product properties, process stages and unit operations involved in the trial may include: 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 warehousing |
Trial specifications | Trial specifications may include: 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 OHS, food safety and environmental hazards and controls storage requirements |
Hazards | Hazards may include: electric shock microbiological organisms and agents associated with soil, air and water solar radiation, dust and noise chemicals, such as acids, heavy metals, pesticides and hydrocarbons aerosols from broken centrifuge tubes and pipetting radiation, such as gamma and X-ray sharps, broken glassware and hand tools flammable liquids and gases cryogenics, such as dry ice and liquid nitrogen fluids under pressure, such as steam and industrial gases sources of ignition disturbance or interruption of services manual handling, working at heights and working in confined spaces crushing, entanglement and cuts associated with moving machinery or falling objects pedestrian and vehicular traffic |
Safety procedures and hazard control measures | Safety procedures and hazard control measures may include: 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's instructions identifying and reporting operating problems or equipment malfunctions cleaning and decontaminating equipment and work areas regularly using enterprise procedures using personal protective clothing and equipment, 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/waste water, gases, smoke, vapour, fumes, odour and particulates to appropriate personnel |
Resources | Resources may include: operators and personnel from affected work areas and functions production, testing and sampling equipment enterprise procedures and standard methods for sampling and testing raw materials/ingredients, packaging components and consumables trial documentation, such as technical specifications, plant or production line layout, MSDS, trial request and result forms |
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 |