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Elements and Performance Criteria

1. Prepare the equipment and process for operation
   • Packaging components/consumables, materialsand items to be packaged are confirmed and available to meetoperating requirements
   • Cleaning and maintenance requirements andstatus are identified and confirmed
   • Machine components and related attachments arefitted and adjusted to meet operating requirements
   • Operating parameters are entered as requiredto meet safety and production requirements
   • Materials, product and packagingcomponents/consumables are loaded or positioned as required to meetpackaging requirements
   • Equipment performance is checked and adjustedas required
   • Pre-start checks are carried out as requiredby workplace requirements
2. Operate and monitor the process
   • The process is started and operated accordingto workplace procedures
   • Equipment is monitored to identify variationin operating conditions
   • Variation in equipment operation is identifiedand maintenance requirements are reported according to workplacereporting requirements
   • The process is monitored to confirm thatspecifications are met
   • Out-of-specification process outcomes areidentified, rectified and/or reported to maintain the processwithin specification
   • The workplace meets housekeeping standards
   • Workplace records are maintained according toworkplace recording requirements
3. Shut down the process
   • The appropriate shutdown procedure isidentified
   • The process is shut down according toworkplace procedures
   • Maintenance requirements are identified andreported according to workplace reporting requirements

Required Skills

Not applicable

Evidence Required

The assessment process must address all of the following items of evidence

Ability to

Access workplace information to identify packaging requirements

Select fit and use personal protective clothing andor equipment

Confirm supply of necessary packaging componentsconsumables materials and services

Conduct prestart checks This may involve inspecting equipment condition to identify any signs of wear setting coders and printers selecting appropriate equipment settings andor related parameters cancelling isolation or lockouts as required confirming that equipment is clean correctly configured for packaging requirements sensors and controls are correctly positioned any scheduled maintenance has been completed and all safety guards are in place and operational

Start operate monitor and adjust packaging equipment to achieve required outcomes This may include loading packaging componentsconsumables andor product monitoring control points such as weights codes placement glue temperatures alignment and appearance configuration and seal integrity as required to confirm process remains within specification

Monitor supply and flow of materials to and from the process

Take corrective action in response to outofspecification results

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 packaging equipment off line in preparation for cleaning andor maintenance within level of responsibility

Demonstrate batchprocess changeovers

Complete workplace records as required

Maintain work area to meet housekeeping standards

May include ability to

Use process control systems

Integrity testing of packaging

Carry out routine maintenance

Clean and sanitize equipment

Knowledge of

Purpose and basic principles of the packaging process This includes an understanding of the purpose and characteristics required of packaging materials used the principles of the packaging process used 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 equipment This may include an operational understanding of main equipment components status and purpose of guards equipment operating capacities and applications and the purpose and location of sensors and related feedback instrumentation It also includes knowledge of services required and action to take if services are not available

The flow of processes supplying the packaging process and the effect of outputs on downstream processes

Quality characteristics required of the packaging process This may include an understanding of the seal integrity requirements

Effect of variation in inputs which may include packaging componentsconsumables materials andor services on process performance

Operating requirements and parameters and corrective action required where operation is outside specified operating parameters This includes an understanding of restart procedures following a crash or jam up

Typical equipment faults and related causes This includes recognition of signs and symptoms of faulty equipment and early warning signs of potential problems

Methods used to monitor the packaging process This may include visual 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

Contaminationfood safety risks related to stages in the packaging process and related control measures

Common causes of variation and corrective action required

OHS hazards and controls

Requirements of different shut downs as appropriate to the packaging process This includes emergency and routine shutdowns and procedures to follow in the event of a power outage This may involve conducting basic equipment referencing

Productpackaging changeover procedures and responsibilities

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 process This includes wasterework 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

Routine maintenance procedures

Packaging integrity testing

Cleaning and sanitation procedures

The assessment process must address all of the following items of evidence

Ability to

Access workplace information to identify packaging requirements

Select fit and use personal protective clothing andor equipment

Confirm supply of necessary packaging componentsconsumables materials and services

Conduct prestart checks This may involve inspecting equipment condition to identify any signs of wear setting coders and printers selecting appropriate equipment settings andor related parameters cancelling isolation or lockouts as required confirming that equipment is clean correctly configured for packaging requirements sensors and controls are correctly positioned any scheduled maintenance has been completed and all safety guards are in place and operational

Start operate monitor and adjust packaging equipment to achieve required outcomes This may include loading packaging componentsconsumables andor product monitoring control points such as weights codes placement glue temperatures alignment and appearance configuration and seal integrity as required to confirm process remains within specification

Monitor supply and flow of materials to and from the process

Take corrective action in response to outofspecification results

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 packaging equipment off line in preparation for cleaning andor maintenance within level of responsibility

Demonstrate batchprocess changeovers

Complete workplace records as required

Maintain work area to meet housekeeping standards

May include ability to

Use process control systems

Integrity testing of packaging

Carry out routine maintenance

Clean and sanitize equipment

Knowledge of

Purpose and basic principles of the packaging process This includes an understanding of the purpose and characteristics required of packaging materials used the principles of the packaging process used 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 equipment This may include an operational understanding of main equipment components status and purpose of guards equipment operating capacities and applications and the purpose and location of sensors and related feedback instrumentation It also includes knowledge of services required and action to take if services are not available

The flow of processes supplying the packaging process and the effect of outputs on downstream processes

Quality characteristics required of the packaging process This may include an understanding of the seal integrity requirements

Effect of variation in inputs which may include packaging componentsconsumables materials andor services on process performance

Operating requirements and parameters and corrective action required where operation is outside specified operating parameters This includes an understanding of restart procedures following a crash or jam up

Typical equipment faults and related causes This includes recognition of signs and symptoms of faulty equipment and early warning signs of potential problems

Methods used to monitor the packaging process This may include visual 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

Contaminationfood safety risks related to stages in the packaging process and related control measures

Common causes of variation and corrective action required

OHS hazards and controls

Requirements of different shut downs as appropriate to the packaging process This includes emergency and routine shutdowns and procedures to follow in the event of a power outage This may involve conducting basic equipment referencing

Productpackaging changeover procedures and responsibilities

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 process This includes wasterework 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

Routine maintenance procedures

Packaging integrity testing

Cleaning and sanitation procedures

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Range Statement

The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.

- 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

- A packaging process may relate to primary and/or secondary packaging activities. It typically requires the operation of a series of related items of equipment to achieve the required outcome. Where a single item of packaging equipment is operated, refer to the unit FDFZPRBE1A Operate basic equipment

- Typical equipment that may form a packaging sub-system includes conveyor systems, filling, sealing, wrapping, thermo-form equipment, case packers, bundlers, ink jet coders, labellers, palletisers, shrink wrappers and strappers

- 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 FDFOPTCRM2 A Conduct routine maintenance

- Shut down procedures may include cleaning. In some cases cleaning may be carried out by a dedicated cleaning crew

- Operation of equipment and processes may require the use of process control panels and systems

The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.

- 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

- A packaging process may relate to primary and/or secondary packaging activities. It typically requires the operation of a series of related items of equipment to achieve the required outcome. Where a single item of packaging equipment is operated, refer to the unit FDFZPRBE1A Operate basic equipment

- Typical equipment that may form a packaging sub-system includes conveyor systems, filling, sealing, wrapping, thermo-form equipment, case packers, bundlers, ink jet coders, labellers, palletisers, shrink wrappers and strappers

- 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 FDFOPTCRM2 A Conduct routine maintenance

- Shut down procedures may include cleaning. In some cases cleaning may be carried out by a dedicated cleaning crew

- Operation of equipment and processes may require the use of process control panels and systems

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