Elements and Performance Criteria

RANGE STATEMENT
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.
Policies and procedures
Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements
Legislative requirements
Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:
relevant Good Manufacturing Practice (GMP) codes
the Therapeutic Goods Act and/or other relevant legislation
legislation covering environmental management, OHS, anti-discrimination and equal opportunity
Workplace information
Workplace information may include:
SOPs
specifications
production schedules and instructions
manufacturers' advice
standard forms and reports
Filling and sealing equipment
Filling and sealing equipment may include:
pumps
aseptic fillers
hermetic sealers
aseptic packaging
Sterilisation methods
Sterilisation methods used may include:
use of heat (dry and steam)
chemicals (gases and liquids)
gamma irradiation
filtration
Operation of equipment and processes
Operation of equipment and processes may require:
the use of process control panels and systems
Shutdown procedures
Shutdown procedures may include:
cleaning (in some cases cleaning may be carried out by a dedicated cleaning crew)
Services
Services are appropriate to the process to be operated. Typical examples include:
power
steam
water
vacuum
compressed and instrumentation air

EVIDENCE GUIDE
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 pre-start checks on equipment used for 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 GMP principles and procedures to work practices
maintain standards of a clean room work environment.

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 and production/packaging schedules
information on equipment capacity and operating parameters
specifications, control points and operating parameters
aseptic filling and sealing process and related equipment and services
materials and packaging components and consumables
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 competency relevant to the function or work role. Examples could be:
FDFOP2003A Clean equipment in place
FDFOP2004A Clean and sanitise equipment
FDFOP2011A Conduct routine maintenance
FDFOP2013A Apply sampling procedures
FDFOP2030A Operate a process control interface
MSL973001A Perform basic tests.

Guidance information for assessment
To ensure consistency in one's 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.