Required skills

Ability to

access workplace information to identify processing requirements

select fit and use personal protective clothing andor equipment including gowning up following required work area entry and exit procedures and moving around the work area to minimise risk of contamination

confirm supply of necessary packaging componentsconsumables and product

conduct prestart checks such as inspecting equipment condition to identify any signs of wear disinfecting and sterilising equipment and surfaces selecting appropriate settings andor related parameters cancelling isolation or lock outs as required confirming that equipment is clean and correctly configured for packaging requirements packaging componentsconsumables are loaded positioning sensors and controls correctly ensuring any scheduled maintenance has been carried out and confirming that all safety guards are in place and operational

start operate monitor and adjust the forming filling and sealing process equipment to achieve required outcomes including monitoring control points and conducting inspections as required to confirm process remains within specification such as

container formation

flow rates

weights and volumes

fill levels

temperature including materials and sealing temperatures

supply of packaging componentsconsumables

packaging quality and seal integrity and where required testing packaging integrity

take corrective action in response to outofspecification results

monitor supply and flow of materials to and from the process

respond to andor report equipment failure within level of responsibility

locate emergency stop functions on equipment

follow isolation and lock outtag out procedures as required to take forming filling and sealing process and related equipment offline in preparation for cleaning andor maintenance within level of responsibility

demonstrate productprocess changeovers

follow endofbatch procedures including line clearance and cleaning yield calculation materials reconciliation and product labelling

complete workplace records as required

maintain work area to meet housekeeping standards

use process control systems according to enterprise procedures

collect samples and conduct tests according to enterprise procedures

use oral communication skillslanguage competence to fulfil the job role as specified by the organisation including questioning active listening asking for clarification and seeking advice from supervisor

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of

purpose and basic principles of forming filling and sealing including the properties of packaging materials used the forming process and principles of heat sterilisation and its effect on microbiological characteristics of the product and packaging materials

aseptic container preparationforming filling and sealing requirements

basic operating principles of aseptic forming filling and sealing equipment such as 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 form fill and seal equipment used in the workplace

quality characteristics and legal requirements to be achieved by the forming filling and sealing process such as understanding quality requirements of packaging componentsconsumables sterilisation requirements and procedures container formation filling fill levels and weights requirements of seal formation and integrity and where relevant integrity testing procedures

the flow of processes supplying the forming filling and sealing process and the effect of process output on downstream processes

operating requirements and parameters and corrective action required where operation is outside specified operating parameters

typical equipment faults and related causes including signs and symptoms of faulty equipment and early warning signs of potential problems

methods used to monitor the process such as inspecting measuring and testing as required by the process

inspection or test points control points in the process and the related procedures and recording requirements

Good Manufacturing Practice GMP requirements associated with the liquid manufacturing process and related control measures

common causes of variation and corrective action required including an understanding of the effect of variation in both product and packaging componentsconsumables on filling and sealing performance eg it may include an understanding of the effect of temperature variation on the filling process

productpackaging changeover procedures

occupational health and safety OHS hazards and controls including the limitations of protective clothing and equipment relevant to the work process

endofbatch procedures including procedures for calculating yield materials reconciliation and action required if yieldreconciliation is not within prescribed limits and product labelling responsibilities and procedures

requirements of different shutdowns as appropriate to the process and workplace production requirements including emergency and routine shutdowns and procedures to follow in the event of a power outage

line clearance cleaning and sanitation procedures

isolation lock out and tag out procedures and responsibilities

procedures and responsibility for reporting production and performance information

environmental issues and controls relevant to the forming filling and sealing process including waste collection and handling procedures related to the process

basic operating principles of process control where relevant including the relationship between control panels and systems and the physical equipment

sampling and testing procedures where relevant

routine maintenance procedures where relevant

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

Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed Competence in this unit must be achieved in accordance with food safety standards and regulations

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of ability to

conduct prestart checks on machinery used for forming fillingand sealing

start operate monitor and adjust process equipment to achieve required quality outcomes

take corrective action in response to typical faults and inconsistencies

complete workplace records as required

apply safe work practices and identify OHS hazards and controls

safely shut down equipment

apply food safety procedures to work practices

Context of and specific resources 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 GMP quality and environmental requirements stock flow systems productionpackaging schedules

information on equipment capacity and operating parameters

specifications control points and operating parameters

aseptic forming filling and sealing process and related equipment and services

materials and packaging componentsconsumables to be formed filled and sealed

product

sampling schedules and test procedures and equipment as required

documentation and recording requirements and procedures

cleaning procedures materials and equipment as required

Method of assessment

This unit should be assessed together with core units and other units of competence relevant to the function or work role Examples could be

FDFOPA Clean equipment in place

FDFOP2003A Clean equipment in place

FDFOPA Clean and sanitise equipment

FDFOP2004A Clean and sanitise equipment

FDFOPA Conduct routine maintenance

FDFOP2011A Conduct routine maintenance

FDFOPA Apply sampling procedures

FDFOP2013A Apply sampling procedures

FDFOPA Operate a process control interface

FDFOP2030A Operate a process control interface

MSLA Perform basic tests

MSL973001A Perform basic tests.

Guidance information for assessment

To ensure consistency in ones performance competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances cases and responsibilities and where possible over a number of assessment activities

Policies and procedures

Legislative requirements

Workplace information

Forming, filling and sealing equipment

Sterilisation methods

Operation of equipment and processes

Shutdown procedures

Services