Elements and Performance Criteria

Range description
Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements
Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes labelling, weights and measures legislation; and legislation covering food safety, environmental management, occupational health and safety, anti-discrimination and equal opportunity. When applied to the pharmaceutical industry, relevant GMP codes apply in place of the Australian Food Standards Code and reference to food safety is replaced by GMP
Workplace information may include Standard Operating Procedures (SOPs), specifications, production schedules and instructions, manufacturers' advice, standard forms and reports
Filling and sealing equipment may include pumps, fillers including aseptic bottle fillers, hermetic sealers, bag fillers, aseptic packaging, seamers, level detection equipment and conveyors. Related processes depend on product requirements and may include product preparation equipment such as mixers, blenders, carbonators, heat exchangers, chillers, and crystallisers
Operation of equipment and processes may require the use of process control panels and systems
Packaging may include vacuum packing and Modified Atmosphere Packaging (MAP)
Operators carry out changeovers within workplace arrangements and the relevant changeover procedures should be used to customise the details of this unit. Where more detailed changeovers are carried out, also refer to
Shutdown procedures may include cleaning. In some cases cleaning may be carried out by a dedicated cleaning crew
Services are appropriate to the process to be operated. Typical examples include power, steam, water, vacuum, inert gas (where gas flushing is used), and compressed and instrumentation air

Ability to:
Access workplace information to identify filling and packaging requirements
Select, fit and use personal protective clothing and/or equipment
Confirm supply of necessary packaging components/consumables, product and services
Conduct pre-start checks. This may involve inspecting equipment condition to identify any signs of wear; selecting appropriate settings and/or related parameters; cancelling isolation or lockouts as required; and confirming that equipment is clean, correctly configured for packaging requirements, packaging components/consumables are loaded, sensors and controls are correctly positioned, any scheduled maintenance has been completed, and that all safety guards are in place and operational

Start, operate, monitor and adjust the filling and sealing process equipment to achieve required outcomes. This may include monitoring control points and conducting inspections as required to confirm process remains within specification. This may include monitoring:

flow rates
product weights and volumes
fill levels
times and temperatures - includes product and sealing temperatures
supply of packaging components/consumables
packaging quality and seal integrity. This may include testing seal integrity
Take corrective action in response to out-of-specification results
Respond to and/or report equipment failure within level of responsibility
Locate emergency stop functions on equipment
Follow isolation and lock out/tag out procedures as required to take filling and sealing process and related equipment off-line in preparation for cleaning and/or maintenance within level of responsibility
Prepare filling and sealing equipment for cleaning
Demonstrate product/process changeovers
Complete workplace records as required
Maintain work area to meet housekeeping standards

May include ability to:

Use process control systems
Demonstrate aseptic filling and sealing procedures
Collect samples and conduct tests
Clean and sanitize equipment

Knowledge of:
Purpose and basic principles of filling and sealing. This includes an understanding of the purpose and characteristics required of packaging materials used and the method used to fill and seal product. Where methods involve vacuum or MAP packaging, it includes an understanding of the effect of modified atmosphere on product shelf-life
Product and packaging coding requirements and related legal requirements including product weight
Basic operating principles of filling and sealing equipment. This may include an operational understanding of main equipment components; status and purpose of guards; equipment operating capacities and applications; the purpose and location of sensors and related feedback instrumentation; and services required for operation of filling equipment used in the workplace
The flow of processes supplying the filling and sealing process and the effect of outputs on downstream processes
Quality characteristics and requirements of filling and sealing. This may include an understanding of quality requirements of product and packaging components/consumables, requirements of filling including fill levels and weights, requirements of seal formation and integrity. It may require an understanding of integrity testing procedures
Methods used to monitor the process. This may include inspecting, measuring and testing as required by the process. It requires awareness of inspection or test points (control points) in the process and the related procedures and recording requirements
Operating requirements and parameters and corrective action required where operation is outside specified operating parameters. This includes an understanding of procedures to clear a breach and restart following a crash or jam up as appropriate
Typical equipment faults and related causes. This includes recognition of signs and symptoms of faulty equipment and early warning signs of potential problems
Common causes of variation and corrective action required. This includes an understanding of the effect of variation in both product and packaging components/consumables on filling and sealing performance. For example, it may include an understanding of the effect of temperature variation on the filling process
Food safety hazards and risks associated with filling and sealing and related control measures
OHS hazards and controls
Requirements of different shutdowns as appropriate to the process and workplace production requirements. This includes emergency and routine shutdowns and procedures to follow in the event of a power outage
Isolation, lock out and tag out procedures and responsibilities
Product/packaging changeover procedures
Procedures and responsibility for reporting production and performance information
Environmental issues and controls relevant to the filling and sealing process. This includes waste/rework collection and handling procedures related to the process

May include knowledge of:

Basic operating principles of process control where relevant. This includes the relationship between control panels and systems and the physical equipment
Aseptic filling and sealing requirements
Sampling and testing procedures
Cleaning and sanitizing procedures

Relationship with other standards
Pre-requisite units
There are no pre-requisite units for this competency standard.
Co-assessment of related units

This unit should be assessed together with core units and other units of competence relevant to the function or work role. In addition, the following optional or ancillary units may be relevant:

FDFZPRCI2A Operate a process control interface
FDFOPTISP2A Implement sampling procedures
PMLTEST300A Perform basic tests
FDFOPTCRM2A Conduct routine maintenance
FDFZCSCIP2A Clean equipment in place
FDFZCSCS2A Clean and sanitize equipment

Resources required for assessment

Assessment must occur in a real or simulated workplace where the assessee has access to:

Personal protective clothing and equipment
Work procedures including advice on safe work practices, food safety, quality and environmental requirements, stock flow systems, production/packaging schedules
Information on equipment capacity and operating parameters
Specifications, control points and operating parameters
Filling and sealing process and related equipment and services
Materials and packaging components/consumables to be formed and filled
Product
Sampling schedules and test procedures and equipment as required
Documentation and recording requirements and procedures
Cleaning procedures, materials and equipment as required

Assessment requirements
For information on how to assess this competency standard and who can assess, refer to the Assessment Guidelines for this Training Package.