Required skills

Ability to

access workplace information to identify liquid manufacturing process requirements

select fit and use personal protective clothing andor equipment

confirm supply of necessary materials and services to the liquid manufacturing process

conduct prestart checks such as inspecting equipment condition to identify any signs of wear selecting appropriate settings andor related parameters cancelling isolation or lockouts as required confirming line clearance and cleaning status ensuring equipment is correctly configured for processing requirements positioning sensors and controls correctly ensuring any scheduled maintenance has been carried out and confirming that all safety guards are in place and operational

addload materials in correct quantities and sequence such as monitoring automatic ingredient addition andor manual addition

start operate monitor and adjust liquid manufacturing process equipment to achieve required outcomes including monitoring control points and conducting inspections as required to confirm process remains within specification

take corrective action in response to outofspecification results

monitor supply and flow of materials to and from the liquid manufacturing process

pace the liquid manufacturing process to meet production requirements

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 liquid manufacturing process and related equipment offline in preparation for cleaning andor maintenance within level of responsibility

demonstrate batchproduct 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

conduct routine maintenance 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 the liquid manufacturing process including the characteristics and basic function of raw materials used and method and sequence of addition required to achieve required mix characteristics and where required the characteristics of solutions suspensions and emulsions

basic understanding of specific gravity and bulk density as appropriate for ingredients used

basic operating principles of liquid manufacturing 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 awareness of calibration schedules for scales and related weighingmeasuring equipment

services required and action to take if services are not available

stages and changes which occur during liquid manufacturing

quality characteristics and legal requirements to be achieved by the liquid manufacturing process

the flow of the liquid manufacturing process and the effect of outputs on downstream pharmaceutical 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 liquid manufacturing process such as inspecting measuring and testing as required by the process

inspection or test points control points in the liquid manufacturing process and the related procedures and recording requirements including monitoring

flow rates

materials addition sequence

timestemperatures and agitator speeds

required characteristics of manufactured liquid

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

common causes of variation and corrective action required

productprocess changeover procedures and responsibilities

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 liquid manufacturing 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 liquid manufacturing 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 associated with process monitoring and control 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 equipment used for liquid manufacturing process

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 assessee has access to

personal protective clothing and equipment

work procedures including advice on safe work practices GMP quality and environmental requirements

information on equipment capacity and operating parameters

production schedulebatch instructions

specifications control points and processing parameters

liquid manufacturing process and related equipment and services

materials required for the liquid manufacturing process

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 competency 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

Liquid manufacturing

Stock

Operation of equipment and processes

Work

Shutdown procedures

Services